MAUDE Adverse Event Report: STRYKER GMBH STERILE WRIST KIT HOFFMANN II COMPACT; IMPLANT

Catalog Number 49409820

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 02/03/2018

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Hoffmann pin broke off in insertion wrench, sterile single use kit.

Manufacturer Narrative

The reported event that sterile wrist kit hoffmann ii compact was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.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.Some possible causes, not limited to, could be: - hard/dense bone - too high torque applied - interference with object - wrong surgical technique a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.Device was not return.

Event Description

Hoffmann pin broke off in insertion wrench, sterile single use kit.

• Brand Name: STERILE WRIST KIT HOFFMANN II COMPACT
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7306073
• MDR Text Key: 101480209
• Report Number: 0008031020-2018-00149
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 49409820
• Device Lot Number: L47397
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 25 YR