MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM; PIN, FIXATION, THREADED

Catalog Number	50382110S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.
Event or Problem Description
Broken 3mm apex pins during removal from bone.
Additional Manufacturer Narrative
The reported event that self-drilling half pin apex ø 3mm, 110 x 25mm was alleged of 'breakage during surgery' could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.Based on investigation, the root cause was attributed to be user related.The failure was caused by an off-labelling usage.Indeed, it was reported the apex pin was used for navigation procedure.Please note that the operative technique (apex-st-1 en apex pins op tech) reads: ''caution: apex pins are not intended for navigation procedure purposes.Therefore, this case is considered as user related.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.
Event or Problem Description
Broken 3mm apex pins during removal from bone.

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 3MM, 110 X 25MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 7732855
• Report Number: 0008031020-2018-00528
• Device Sequence Number: 1316386
• Product Code: JDW
• UDI-Device Identifier: 04546540435408
• UDI-Public: 04546540435408
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K001886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 50382110S
• Device Lot Number: Y05310
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2018
• Supplement Date Received by Manufacturer: 09/06/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR