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U.S. Department of Health and Human Services

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

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STRYKER GMBH UNKNOWN TWINFIX COMPRESSION SCREW IMPLANT Back to Search Results
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. ¿.
 
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Brand NameUNKNOWN TWINFIX COMPRESSION SCREW
Type of DeviceIMPLANT
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 Key8766755
MDR Text Key150531046
Report Number0008031020-2019-00763
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Number of Events Reported1
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 Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_SEL
Device Lot NumberUNKNOWN
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 Received06/10/2019
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
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