MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN TWINFIX COMPRESSION SCREW IMPLANT

Catalog Number UNK_SEL

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2010

Event Type  Injury  

Manufacturer Narrative

Device will not be returned. If additional information becomes available, it will be provided in a supplemental report. Device evaluated by mfr: device disposition unknown.

Event Description

The manufacturer became aware of a study from (b)(6) university, (b)(6). The title of this report is ¿percutaneous fixation for scaphoid nonunion with bone grafting through the distal insertion hole of a fully threaded headless screw¿ which was published in august 2018 and is associated with the stryker twinfix screw. Within that publication, post-operative complications/ adverse events were reported, which occurred between 2010 and 2013. It was not possible to ascertain specific device catalog/lot information from the report; a review of the complaint handling database, however, revealed that the events have not been reported by the hospital or by the author of the publication. Therefore, 1 complaint was initiated retrospectively for different adverse events mentioned in the report. This product inquiry addresses screw protrusion and revision. The study reports, ¿one of the six patients underwent surgery to remove the screw because of slight protrusion of the screw head from the proximal articular surface of the scaphoid. [¿] open reduction and internal fixation had been performed previously using a double-threaded headless screw [¿] via a palmar approach 6 months before revision surgery. We removed the retrogradely inserted screw from a 7-mm skin incision over the volar side of the trapezium. ¿.

• Brand Name: UNKNOWN TWINFIX COMPRESSION SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8766755
• MDR Text Key: 150531046
• Report Number: 0008031020-2019-00763
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/08/2019 Patient Sequence Number: 1