MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX 3MM, 80 X 15MM; PIN, FIXATION, THREADED

Model Number 5038-2-080

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2020

Event Type  malfunction  

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device was discarded.

Event Description

As reported: "facial trauma, external fixation.Pin fractured off while fixating to bone.Only 2 threads into bone and rest of pin was stuck in handle.Dr was able to "chuck" the bit of bone out of the bone.Case ended successfully." additionally reported: "pin was used for a mandible fracture.Ex fix on the patients right".

Event Description

As reported: "facial trauma, external fixation.Pin fractured off while fixating to bone.Only 2 threads into bone and rest of pin was stuck in handle.Dr was able to "chuck" the bit of bone out of the bone.Case ended successfully." additionally reported: "pin was used for a mandible fracture.Ex fix on the patients right".

Manufacturer Narrative

The reported event could be confirmed only based on the pictures sent.Based on investigation, the root cause was attributed to be user related.The failure was caused by the misuse of the product (off label use).The complaint reported that the apex pin broke during a trauma facial procedure.However, stryker's apex pins are not intended to be used for facial trauma purposes.Therefore, this case is classified as a user related issue, as there was a deviation from the operative 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.

• Brand Name: SELF-DRILLING HALF PIN APEX 3MM, 80 X 15MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 9907921
• MDR Text Key: 193425910
• Report Number: 0008031020-2020-00900
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091779
• UDI-Public: 07613327091779
• Combination Product (y/n): N
• PMA/PMN Number: K861766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5038-2-080
• Device Catalogue Number: 50382080
• Device Lot Number: Y26128
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1