MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for LONG K-WIRE- NITINOL 48-9016 manufactured by Precision Spine, Inc.
[44333579]
Tip of nitinol guidewire remains in patient's bone (retained foreign object). Evaluation in process but not yet complete. Upon completion of evaluation, a follow up report will be submitted. Evaluation in process, not yet complete.
Patient Sequence No: 1, Text Type: N, H10
[44333580]
It was reported that a 2 level plif l4-s1 fixation was performed in (b)(6) on (b)(6) 2016, to address lumbar spinal stenosis. Pss screws were used for an open case. Guidewires were used for inserting the screws due to the long screwdriver obstructing the view. Six guidewires were placed and the position was confirmed, then the screws were inserted. When the 5th screw (l5 left) was being inserted, a cracking sound was heard and it was confirmed that the guidewire (long k-wire- nitinol p/n 48-9016) had broken about 10mm from the tip. A tap was used to insert the screw and all other screws were inserted successfully without issue. The broken tip of the k-wire was unable to be removed and remains in the patient's bone.
Patient Sequence No: 1, Text Type: D, B5
[45818654]
Dimensional evaluation performed by quality found the returned product conforms to design specifications for the portion of the device remaining. Engineering evaluation of the returned guidewire and manufacturing history inspection sheets did not find any deviations or anomalies. The fracture occurred at the root of the thread and appears to be a shear fracture. Details provided regarding the incident were not enough to make any conclusions as to the cause of the fracture. The breakage may have been attributed to off axis loading while inserting the screw, as the incident notes indicated that the screw driver was obstructing the view of the surgeon for being too long. The surgical technique (lbl-stg-022) surelok slc extended tab pedicle screw system, indicates that k-wires should not be reused if deformed, in order to prevent the k-wire from becoming obstructions in a mating cannulated instruments. Although the exact cause of the fracture could not be confirmed, there was no evidence found that would suggest product error was a contributing factor. Review of manufacturing history records found a total of (b)(4) pieces of this lot were released for distribution on 7/10/2014 with no deviation or anomalies. A two-year complaint history review did not reveal any previous reports of this nature for the reported lot / design revision. As the root cause is likely attributed to off axis loading and no product non-conformance was identified, the need for corrective action was not indicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005739886-2016-00021 |
| MDR Report Key | 5625639 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-05 |
| Date of Event | 2016-03-30 |
| Date Mfgr Received | 2016-04-05 |
| Device Manufacturer Date | 2014-07-10 |
| Date Added to Maude | 2016-05-03 |
| 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 | BETH ALBERT |
| Manufacturer Street | 2050 EXECUTIVE DRIVE |
| Manufacturer City | PEARL MS 39208 |
| Manufacturer Country | US |
| Manufacturer Postal | 39208 |
| Manufacturer Phone | 6014204244 |
| Manufacturer G1 | PRECISION SPINE, INC |
| Manufacturer Street | 2050 EXECUTIVE DRIVE |
| Manufacturer City | PEARL MS 39208 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 39208 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LONG K-WIRE- NITINOL |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2016-05-03 |
| Returned To Mfg | 2016-04-28 |
| Model Number | NA |
| Catalog Number | 48-9016 |
| Lot Number | 0701141 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRECISION SPINE, INC |
| Manufacturer Address | 2050 EXECUTIVE DRIVE PEARL MS 39208 US 39208 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-03 |