MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW AXSOS 5.0MM / L46MM; PLATE, FIXATION, BONE

Catalog Number 371346S

Device Problem Material Fragmentation (1261)

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

Event Date 02/25/2021

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; device remains implanted in patient.

Event Description

It was reported that : "the surgeon found the screw thread in the wound while screwing a screw into the diaphysis.".

Manufacturer Narrative

The reported event could be confirmed, although the device was not returned but an image was shared which 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.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.However, based on the picture provided by the customer, one of the most probable root causes of stripping of threads could be: insertion of screw under high force at an angle greater than required (as per operative technique).If the device is returned or any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that : "the surgeon found the screw thread in the wound while screwing a screw into the diaphysis.".

• Brand Name: LOCKING SCREW AXSOS 5.0MM / L46MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11638302
• MDR Text Key: 252363364
• Report Number: 0008031020-2021-00143
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 371346S
• Device Lot Number: V28398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1