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

Catalog Number 50382110S

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/30/2019

Event Type  malfunction  

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 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
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: kevin smith ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 8946783
• MDR Text Key: 161701105
• Report Number: 0008031020-2019-01192
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 04546540435408
• UDI-Public: 04546540435408
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K001886
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1