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

Catalog Number 50382110

Device Problems Break (1069); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

Apex pin broke upon insertion into patient left femur.Metal tip from apex pin left in left femur.

Manufacturer Narrative

The reported incident that self-drilling half pin apex ø 3mm, 110 x 25mm was allegedly broken during insertion could be confirmed.The device inspection revealed that the pin is broken on the tip and part of that tip is missing, confirming the breakage reported in the complaint.Based on investigation, the root cause was attributed to a r&d/design related issue.The failure was caused by too high tolerances on the tip of the pin.An nc and capa have been open to address the recurring situation of the self-drilling half pin apex ø 3mm breakages.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 or manufacturing related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

Event Description

Apex pin broke upon insertion into patient left femur.Metal tip from apex pin left in left femur.

• 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: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5196615
• MDR Text Key: 30205860
• Report Number: 0008031020-2015-00450
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K861766
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 50382110
• Device Lot Number: J22987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 114