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

Catalog Number UNK_SEL

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Failure of Implant (1924); Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Date 01/01/2015

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 pmcf report (b)(6).The title of this report is ¿performance and safety of autofix-screws in fore and midfoot surgery: a retrospective data analysis¿ which is associated with the stryker autofix screw system.Within that publication, postoperative complications/ adverse events were reported which occurred between january 2015 and december 2018.It was not possible to ascertain specific device catalog or patient details 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 16 complaint was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses wound dehiscence with osteomyelitis and nonunion.2 out of 6 cases.

Manufacturer Narrative

New information in section h6 (device code and patient code).

Event Description

The manufacturer became aware of a pmcf report from foot and ankle centre hirslanden, switzerland.The title of this report is ¿performance and safety of autofix-screws in foreand midfoot surgery: a retrospective data analysis¿ which is associated with the stryker autofix screw system.Within that publication, postoperative complications/ adverse events were reported which occurred between january 2015 and december 2018.It was not possible to ascertain specific device catalog or patient details 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 16 complaint was initiated retrospectively for adverse event mentioned in the study.This product inquiry addresses wound dehiscence with osteomyelitis and nonunion.2 out of 6 cases.

• Brand Name: UNKNOWN AUTOFIX SCREW
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9371348
• MDR Text Key: 184879250
• Report Number: 0008031020-2019-01879
• Device Sequence Number: 1
• Product Code: FSM
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other