MAUDE Adverse Event Report: STRYKER GMBH UNKNOWN AUTOFIX SCREW; IMPLANT

Catalog Number UNK_SEL

Device Problems Appropriate Term/Code Not Available (3191); Migration (4003)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 09/01/2002

Event Type  Injury  

Manufacturer Narrative

This complaint has been reported during a literature review performed by the post market surveillance group.The reported event could not be confirmed, since the device was not returned for evaluation and no other additional information is available.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The device history record could not be reviewed because the affected lot number was not communicated.If any further information is provided, the investigation report will be updated.Device disposition is unknown.

Event Description

The manufacturer became aware of a study from (b)(6).The title of this report is ¿percutaneous osteosynthesis of the scaphoid: a retrospective study of 93 cases and review of the literature¿ which is associated with the stryker autofix screw system.Within that publication, postoperative complications/ adverse events were reported which occurred between september 2002 and october 2010.It was not possible to ascertain specific device catalog or patient details from the study, 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 4 complaints were initiated retrospectively for adverse events mentioned in the study.This product inquiry addresses early secondary displacement which required surgical revision.

Event Description

The manufacturer became aware of a study from 'faculté de médecine de nancy, france'.The title of this report is ¿percutaneous osteosynthesis of the scaphoid: a retrospective study of 93 cases and review of the literature¿ which is associated with the stryker autofix screw system.Within that publication, postoperative complications/ adverse events were reported which occurred between september 2002 and october 2010.It was not possible to ascertain specific device catalog or patient details from the study, 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 4 complaints were initiated retrospectively for adverse events mentioned in the study.This product inquiry addresses early secondary displacement which required surgical revision.

• Brand Name: UNKNOWN AUTOFIX SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9367607
• MDR Text Key: 184867240
• Report Number: 0008031020-2019-01875
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_SEL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention