MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO T2 FEMUR Ø4,2X180 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-4270
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The following was reported via medwatch (b)(4): a stryker drill bit broke and within the body of the medial calcaneus during the procedure.The drill bit was noted to be within the substance of the bone and was left in place.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.The device inspection was not possible as the product was not returned 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.More detailed information about the complaint event as well as the affected device must be available to determine the root cause of the complaint event.With the available information, it was observed that a t2 femur drill was used in an ankle surgery.The device is not intended to be used in ankle related surgery, hence this potentially a case of an off-label use if device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
The following was reported via medwatch (b)(4): a stryker drill bit broke and within the body of the medial calcaneus during the procedure.The drill bit was noted to be within the substance of the bone and was left in place.

• Brand Name: DRILL, AO T2 FEMUR Ø4,2X180 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12601906
• Report Number: 0009610622-2021-00743
• Device Sequence Number: 14349021
• Product Code: HWE
• UDI-Device Identifier: 04546540196804
• UDI-Public: 04546540196804
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2021

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: 1806-4270
• Device Catalogue Number: 18064270
• Device Lot Number: K07AA83
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 10/09/2021
• Supplement Report FDA Received Date: 12/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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: 57 YR
• Patient Sex: Female