MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO SMALL GAMMA3 Ø4.2X300MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13203042
Medical Device Problem Codes	Break (1069); Fracture (1260); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "drill bit breakage during a gamma per trochanteric nailing procedure.Static assembly lock sought but bit broke against nail.Procedure was completed by dynamic distal aiming.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "drill bit breakage during a gamma per trochanteric nailing procedure.Static assembly lock sought but bit broke against nail.Procedure was completed by dynamic distal aiming.".
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available.It was communicated that the drill broke as a result of hitting the nail.However, due to the lack of evidence this could not be confirmed.Furthermore, it was not possible to determine why the misdrilling occurred.It was not possible to make any statement regarding an user related error or a targeting device related issue.Therefore, the root cause of the reported event could not be determined.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.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "drill bit breakage during a gamma per trochanteric nailing procedure.Static assembly lock sought but bit broke against nail.Procedure was completed by dynamic distal aiming.".
Additional Manufacturer Narrative
Corrections: please refer to sections d9/h3 the device was returned for evaluation, and h6 (method and results codes).The reported event could be confirmed during the investigation performed.The device inspection revealed the following: the identification of the returned drill could be confirmed based on the catalog # and the lot # marked.The drill is broken at the flutes, the detached fragment was not returned.The surface of the breakage give indication of a sudden brittle fracture, most probably due to contact with a metallic object, confirming the reported event.Furthermore, the flutes of the drill are highly worn out, which could be a result of the misdrilling.Dimensional and material integrity inspection showed the device to be within specification.It was communicated that the drill broke as a result of hitting the nail, which could be confirmed during the visual inspection of the implant.However, due to the lack of x-rays and given the targeting device has not been returned, it was not possible to make any statement regarding an user related error or a targeting device related issue.Therefore, the root cause of the reported event could not be determined.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.If any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO SMALL GAMMA3 Ø4.2X300MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20989729
• Report Number: 0009610622-2024-00963
• Device Sequence Number: 15580835
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2025

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 Catalogue Number: 13203042
• Device Lot Number: KU106469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/25/2024
• Supplement Date Received by Manufacturer: 01/23/2025; 07/22/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/18/2025; 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 88 KG