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

Catalog Number	50165111
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/17/2024
Type of Reportable Event	Serious Injury
Event or Problem 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.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received products shows that the pins are broken apart at the tip section.The breakage area shows clear sings of deformation as twisting, from screwing in, before the pins then broke.Deformation like this are a clear indication of high applied mechanical force, were the material will break in fatigue.The returned tips are in heavily damaged condition, strong material deformation, which is most likely the result of removal with pliers.No further investigation or/and statement possible to this badly damaged tips.Dimensional inspection, the measurements taken are all within accuracy.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.Based on investigation, the root cause was attributed to a use related issue.The failure was caused most likely by to much force.If more information is provided, the case will be reassessed.
Event or Problem 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.".

• Brand Name: SELF-DRILLING HALF PIN APEX Ø 5MM, 120 X 35MM
• Common Device Name: 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
• Report Number: 0008031020-2024-00121
• Device Sequence Number: 12505218
• Product Code: JDW
• UDI-Device Identifier: 07613327091885
• UDI-Public: 07613327091885
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K982068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 50165111
• Device Lot Number: K75870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/15/2024
• Supplement Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female