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

Model Number	1320-3042
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
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.Device disposition unknown.
Event or Problem Description
As reported: "during the procedure, a piece of drill bit got stuck in the patient's femoral shaft, whose bone quality was poor.The surgeon preferred not to insist on this procedure because of the risk of damaging the bone, given the patient's life expectancy.Because the piece of drill bit remained in the patient, the event is considered a serious event." the patient had metastases and a very hard bone.In no case it is a problem of the drill.The fact that a piece of drill remains in the patient, is not serious.
Event or Problem Description
As reported: "during the procedure, a piece of drill bit got stuck in the patient's femoral shaft, whose bone quality was poor.The surgeon preferred not to insist on this procedure because of the risk of damaging the bone, given the patient's life expectancy.Because the piece of drill bit remained in the patient, the event is considered a serious event." the patient had metastases and a very hard bone.In no case it is a problem of the drill.The fact that a piece of drill remains in the patient, is not serious.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences 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.Based on investigation and the provided information, the root cause was attributed to a patient related issue.The available information indicates failure was caused by a mechanical overload caused by very hard bone related to metastases.If the device is returned or 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 TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• 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: 15911569
• Report Number: 0009610622-2022-00568
• Device Sequence Number: 19462788
• Product Code: LXH
• UDI-Device Identifier: 04546540377883
• UDI-Public: 04546540377883
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 02/06/2023

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 Model Number: 1320-3042
• Device Catalogue Number: 13203042
• Device Lot Number: KU105559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2019
• 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 Sex: Unknown