MAUDE Adverse Event Report: STRYKER GMBH DRILL, AO SMALL GAMMA3 Ø4.2 X 300 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	13203042S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported by the customer that the "single use 4.2 drill bit snapped into two while drilling.One piece was stuck inside the patient's femur and had to be removed with kelly forceps." it was later confirmed by the surgeon that this event was confirmed to be a user error with no issue with the drill bit itself.The nail was completely broken into 2 pieces at this point in the nail.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidence were provided.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported by the customer that the "single use 4.2 drill bit snapped into two while drilling.One piece was stuck inside the patient's femur and had to be removed with kelly forceps." it was later confirmed by the surgeon that this event was confirmed to be a user error with no issue with the drill bit itself.The nail was completely broken into 2 pieces at this point in the nail.

• Brand Name: DRILL, AO SMALL GAMMA3 Ø4.2 X 300 MM
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 20360342
• Report Number: 0009610622-2024-00844
• Device Sequence Number: 8127251
• Product Code: LXH
• UDI-Device Identifier: 04546540377890
• UDI-Public: (01)04546540377890(11)240513(17)290430(10)K1BAD95
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: 13203042S
• Device Lot Number: K1BAD95
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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: Other
• Patient Sex: Unknown