MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO, STERILE T2 FEMUR Ø5,0X340 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-5020S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "a piece of drill broke off in patient, to be left in as per surgeon".It was reported that the drill bit piece remains in patient as it was determined it could cause damage if attempts were made to remove.
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.Discarded/retained by customer.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned, and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.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 "a piece of drill broke off in patient, to be left in as per surgeon".It was reported that the drill bit piece remains in patient as it was determined it could cause damage if attempts were made to remove.

• Brand Name: DRILL, AO, STERILE T2 FEMUR Ø5,0X340 MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 16308661
• Report Number: 0009610622-2023-00025
• Device Sequence Number: 6792022
• Product Code: HWE
• UDI-Device Identifier: 04546540197016
• UDI-Public: 04546540197016
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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 Expiration Date: 02/29/2024
• Device Model Number: 1806-5020S
• Device Catalogue Number: 18065020S
• Device Lot Number: K02858C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• 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
• Patient Sex: Unknown