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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
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.The operative technique guide 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 guide.A review of the device history for the reported lots 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
Apex pins were used to attach an ortholock to the tibia during a navigated total knee.The tip of the apex pin drill was broken at the time of removal of the pin from the tibial shaft and retained in the 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: 8946783
• Report Number: 0008031020-2019-01192
• Device Sequence Number: 13963478
• 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
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/29/2019

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 Catalogue Number: 50382110S
• Device Lot Number: Y60120 OR Y57249 OR Y11182
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1