MAUDE Adverse Event Report: STRYKER GMBH WRIST LEFT RADIAL IMPLANT, MEDIUM; PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED

Catalog Number WARLM

Device Problems Expiration Date Error (2528); Device Handling Problem (3265)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.

Event Description

The following was reported: we prepared the radius bone and the carpal bone to accommodate medium sized implants, however, while checking the implants boxes the radius component was expired.This resulted in going down a size, fill the hole already done in both radius and carpal bone so we could accommodate a small sized implant.The surgery went ahead with no further complications.

Manufacturer Narrative

H6 device problem, method, results, conclusion, health impact codes were changed.The reported event could be confirmed, although the device was not returned, but information shared by sales rep confirms the alleged failure.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.A review of the device history for the reported lot did not indicate any abnormalities.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to device-material-shelf-life exceeded.As per the additional information received from our sales representative, a local nc has been opened to investigate the issue.If the device is returned or any additional information is provided, the investigation will be reassessed.

Event Description

The following was reported: we prepared the radius bone and the carpal bone to accommodate medium sized implants, however, while checking the implants boxes the radius component was expired.This resulted in going down a size, fill the hole already done in both radius and carpal bone so we could accommodate a small sized implant.The surgery went ahead with no further complications.

• Brand Name: WRIST LEFT RADIAL IMPLANT, MEDIUM
• Type of Device: PROSTHESIS, WRIST, 3 PART METAL-PLASTIC-METAL ARTICULATION, SEMI-CONSTRAINED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11815724
• MDR Text Key: 252994921
• Report Number: 0008031020-2021-00219
• Device Sequence Number: 1
• Product Code: JWJ
• Combination Product (y/n): N
• PMA/PMN Number: K021859
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: WARLM
• Device Lot Number: 32866001
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1