MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-04-24 for BENDER RIGHT 279712850 manufactured by Depuy Spine Inc.
[143291201]
(b)(4). A complaint investigation will be performed. The complaint product is not available for the investigation. A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information. Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[143291202]
The following was reported: medical story: on (b)(6) 2019, surgery is performed to correct scoliosis of the patient's initial fc. The instruments to be used provided by patient's medical coverage and expidiurn depuy spine from the johnson and johnson company. Before starting the surgical procedure, we proceed to the usual control of the material provided by the (b)(4) (distributor). Such control is did by the company instrumentalist (b)(4) who tells us that all the material is fit and there is sufficient number of implants of all sizes. After the confirmation of the instrumentalist the patient is asked to turn to the operating room. When trying to start with the corrective maneuvers and final adjustment of the system we find ourselves with the following difficulties found with the company's instrumentation and the entire surgical team. The front grips are extremely worn and open so it is practically impossible to perform the gripping maneuvers. (video of the maneuver is made). The cut in situ bars is in bad condition and is not suitable for cutting cobalt chrome bars because i do not know hard enough. Bending of the cutting edge of the bars is observed which makes it impossible to cut with the in-situ bars. (pictures were taken). When trying to make the final adjustment of the system, the anti-torque does not work. When we trying to make the final adjustment, due to the wear of the screwdriver it is impossible to reach the end of the adjustment because it rounds the turks of the system. The final adjustment was attempted and 6 consecutive nuts were rounded by the bad condition of the nuts (photos of instruments and nuts). Distributor's story: below, i detail a series of inconveniences too serious and inconceivable that happened in the patient's surgery (initials (b)(6)) commanded by dr. (b)(6). These events can summarized as lack of maintenance and poor condition of all the spinal instruments in the box 41002024. The placement of the polyaxial screws could be completed with some drawback due to the wear of the instruments and when incorporating the inner (ref 179702000), with the precise instruments designed for this and its handle (reference 279712600 x 2 and 272040510) it did not work, the system is completely distorted. These elements are essential to ensure the stability and safety of the expedium system as they ensure that the force used is adequate, without risk of loosening the system and certifying that the surgeon does not exceed the force applied to the system or column. None of this worked. The situation worsened at the time of cutting the cobalt bar (cobalt chrome) in situ, since the shear instead of performing this procedure disintegrated the cutting area with each attempt. This demanded the removal and repositioning of all the inner ones again and modification of the length of the bar outside the spine, promoting complications of all the factors that go to a procedure of these characteristics, such as prolongation of the surgical time and exposure of the tissues. Excessive manipulation of a totally unstable column, increased risk of hemodynamic failure due to increased bleeding in pediatric patients and the fixation system; in addition to the potential risk of surgical site infection due to excessive prolongation of surgery time. Immediately after placing and closing the system in an craft manner, it became necessary to grind the bars in situ, which ended up demonstrating the lack of maintenance of the system, the ends that are assembled in the chrome bar were very worn and the stiffness of the bar made the grif more and more damaged. Situation that resulted in not being able to complete the correction of the deformity. Dr. (b)(6) very dissatisfied with this situation raised a note to (b)(4), where he makes us solely responsible for any failure due to loosening, instability, or surgical site infection. I want to add to this complaint that, due to this very serious system failure, damaged and considered unusable 8 inner ref. 179702000 of which were returned 6 as the doctor discarded them to return to the set and disgust through although we were able to rescue some to send them as a sample. Attached photo of the instruments to validate the information, i wait confirmation that this equipment will not be sent back to surgery without previous exhaustive check and replacement; and thus join us in a common commitment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1526439-2019-51558 |
| MDR Report Key | 8547610 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-04-24 |
| Date of Report | 2019-03-27 |
| Date of Event | 2019-03-22 |
| Date Mfgr Received | 2019-06-18 |
| Device Manufacturer Date | 2012-11-28 |
| Date Added to Maude | 2019-04-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | DEPUY SPINE INC |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BENDER RIGHT |
| Generic Name | BENDER |
| Product Code | HXW |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-04-25 |
| Model Number | 279712850 |
| Catalog Number | 279712850 |
| Lot Number | MI26178 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY SPINE INC |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-24 |