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

Model Number	5038-2-110S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Event or Problem Description
As reported: " 3 x sterile apex pins ref number , 5038-2-110s were used in a navigated high tibial osteotomy case, inserted with a wired driver, upon removal with the wire driver post finishing the case it was noted that the tips of the pins had broken off.Noticed after surgery was completed and removing the pins.".
Event or Problem Description
As reported: " 3 x sterile apex pins ref number, (b)(4) were used in a navigated high tibial osteotomy case, inserted with a wired driver, upon removal with the wire driver post finishing the case it was noted that the tips of the pins had broken off.Noticed after surgery was completed and removing the pins.".
Additional Manufacturer Narrative
The reported event could not be confirmed.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 the navigation procedure.However, the operative technique clearly mentions that the apex pins are not to be used for navigation procedure purposes: " caution: apex pins are not intended for navigation procedure 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, 110 X 25MM
• Common Device Name: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10840129
• Report Number: 0008031020-2020-02447
• Device Sequence Number: 3732703
• Product Code: JDW
• UDI-Device Identifier: 04546540435408
• UDI-Public: 04546540435408
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K001886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 5038-2-110S
• Device Catalogue Number: 50382110S
• Device Lot Number: Y55997
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 114