MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 TIBIA Ø5.0X180 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1806-5010
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "during a t2 tibial nail procedure and under ampliscopic control, the surgeon performed the bone perforation.The tip broke inside the bone.A second drill had to be used, which also broke within the bone.A third tip was used to complete the procedure.Within the patient's tibia, two tip fragments approximately 3-4 mm long remained.".
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.
Additional Manufacturer Narrative
Please note the correction made to the d4 lot #: the reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.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 device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
As reported: "during a t2 tibal nail procedure and under ampliscopic control, the surgeon performed the bone perforation.The tip broke inside the bone.A second drill had to be used, which also broke within the bone.A third tip was used to complete the procedure.Within the patient's tibia, two tip fragments approximately 3-4 mm long remained.".

• Brand Name: DRILL, AO T2 TIBIA Ø5.0X180 MM
• 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: 15993093
• Report Number: 0009610622-2022-00584
• Device Sequence Number: 6151073
• Product Code: LXH
• UDI-Device Identifier: 04546540196965
• UDI-Public: 04546540196965
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 02/07/2023

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: 1806-5010
• Device Catalogue Number: 18065010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 68 YR
• Patient Sex: Unknown