MAUDE Adverse Event Report: STRYKER GMBH SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM; PIN, FIXATION, THREADED

Catalog Number 50165111

Device Problems Break (1069); Fracture (1260)

Patient Problem Perforation (2001)

Event Date 02/17/2024

Event Type  Injury  

Event Description

The following event was received through bfarm user report: "when inserting the fixator pin under typical conditions, it happened twice that both pins from the same batch broke off in exactly the same place.The remnants had to be chiseled out of the bone.The predetermined breaking point had to be bridged.These are "self-tapping / self-drilling" pins.".

Manufacturer Narrative

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

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18911841
• MDR Text Key: 337748071
• Report Number: 0008031020-2024-00121
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07613327091885
• UDI-Public: 07613327091885
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K982068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 50165111
• Device Lot Number: K75870
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• 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: 86 YR
• Patient Sex: Female