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

Catalog Number	13203042S
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was disposed at the hospital.
Event or Problem Description
Primary procedure, left femur.It was reported that the surgeon removed the targeter before locking distally.When then attempting to drill to lock distally, the tip of the drill bit broke off in the patient.The tip remained in patient.A surgical delay of 1 hour was reported.
Event or Problem Description
Primary procedure, left femur.It was reported that the surgeon removed the targeter before locking distally.When then attempting to drill to lock distally, the tip of the drill bit broke off in the patient.The tip remained in patient.A surgical delay of 1 hour was reported.
Additional Manufacturer Narrative
The reported event that drill, ao small gamma3 4.2x300mm was alleged of issue -a (instruments - drill - broken) could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for 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.However, based on the risk management file and complaint history, some of the possible causes could be handling failure, mechanical overstressing etc.As per risk management file, in most cases breakage of a drill does not cause much problem because the fragments are easily removable and no significant soft tissue damage would occur.A review of the labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: DRILL, AO SMALL GAMMA3® Ø4.2 X 300 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 7727758
• Report Number: 0009610622-2018-00402
• Device Sequence Number: 1588106
• Product Code: LXH
• UDI-Device Identifier: 04546540377890
• UDI-Public: 04546540377890
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 13203042S
• Device Lot Number: K024605
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR