MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-06-16 for IMPLANT DRIVER HOLDER ASSEMBLY 800-1212 manufactured by Osteomed L.p..
[19660997]
The surgeon attached an ff screw (b)(4) to the implant driver holder assembly ((b)(4)) to begin placing the screw. While placing the screw into the prepared hole and beginning to thread into place, the tip of the implant holder assembly sheared, leaving the instrument unable to retain the ff screw. The components were removed, the implant holder assembly was replaced with the second unit in the kit, and the surgeon re-inserted. When he was close to fully seating the ff screw, he again felt the tip of the implant holder assembly shear. With the screw partially inserted into the facet, the surgeon removed the implant driver assembly, but was unable to retrieve the fragment of the threaded tip from inside the ff screw. Using the removal driver, the surgeon was able to successfully thread the ff screw to depth.
Patient Sequence No: 1, Text Type: D, B5
[19754553]
At this time, the investigation points to the difference in the shape of the thread form at the tip as potentially the most likely root cause of the thread failure of the driver stem that was observed in the field. The procedure was performed as an "open" procedure without a k-wire. The ifu and stg reference the use of a k-wire during placement. Decision was made on (b)(4) 2011, to recall the product. (b)(6) was notified on (b)(4) 2011. Formal report submitted on (b)(4) 2011.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027754-2011-00004 |
| MDR Report Key | 2140346 |
| Report Source | 05,07 |
| Date Received | 2011-06-16 |
| Date of Report | 2011-06-16 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-06-01 |
| Device Manufacturer Date | 2011-02-01 |
| Date Added to Maude | 2012-04-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 3885 ARAPAHO RD. |
| Manufacturer City | ADDISON TX 75001 |
| Manufacturer Country | US |
| Manufacturer Postal | 75001 |
| Manufacturer Phone | 9726774787 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 027754-06/16/2011-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPLANT DRIVER HOLDER ASSEMBLY |
| Generic Name | ORTHOPAEDIC SURGICAL INSTRUMENT |
| Product Code | MRW |
| Date Received | 2011-06-16 |
| Returned To Mfg | 2011-06-07 |
| Model Number | 800-1212 |
| Catalog Number | 800-1212 |
| Lot Number | 1038452 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSTEOMED L.P. |
| Manufacturer Address | ADDISON TX US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-16 |