MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL, AO, STERILE T2 HUMERUS Ø3,5X230 MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	1806-3540S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was doing a t2 humeral nail and that, while performing the proximal locking, after inserting a oblique screw, an attempt to drill a proximal transverse screw was done and the drill bit seemed to have broken.The piece remains in the humeral head.No further effort was made to retrieve and there was no adverse consequence or extended or time.
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 discarded by customer.
Additional Manufacturer Narrative
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.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.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
It was reported that the surgeon was doing a t2 humeral nail and that, while performing the proximal locking, after inserting a oblique screw, an attempt to drill a proximal transverse screw was done and the drill bit seemed to have broken.The piece remains in the humeral head.No further effort was made to retrieve and there was no adverse consequence or extended or time.

• Brand Name: DRILL, AO, STERILE T2 HUMERUS Ø3,5X230 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: 15588688
• Report Number: 0009610622-2022-00462
• Device Sequence Number: 17934590
• Product Code: HWE
• UDI-Device Identifier: 04546540196613
• UDI-Public: 04546540196613
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2022

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: 1806-3540S
• Device Catalogue Number: 18063540S
• Device Lot Number: K07DFF1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2022
• 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 Age: 58 YR
• Patient Sex: Unknown