MAUDE Adverse Event Report: STRYKER TRAUMA KIEL DRILL-TIP RECON K-WIRE IMN INSTRUMENTS Ø3.2X400MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	2351-3240S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.Device remains in patient.
Event or Problem Description
It was reported approximately 10mm of k-wire broke off inside the patient as the surgeon was drilling it.The wire was left inside the patient's bone.There were no adverse consequences to the patient as a result of this event.
Additional Manufacturer Narrative
The reported event could be confirmed, since the x-ray was provided for evaluation and matches the alleged failure mode.A device inspection was not possible since the affected device was not returned, and no other evidence 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.Formal medical opinion was sought from an experienced independent medical expert as below; ¿yes, k-wire is still in the patient.An intraoperative breakage of a drill is a rare but common complication and well known to an experienced user.It is caused by twisting the drill and too much bending.Breakage caused by material defect is very rare in current manufacturing technology.It is of interest whether a broken part of a drill can be left in the bone or should be retrieved; also in the case that greater harm to the bone would be done.¿ based on investigation, the root cause was primarily attributed to a user related issue.It is caused by twisting the drill and bending it too much.The ifu also instructs user to always treat the instrument carefully to avoid surface damage or alterations to the geometry.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported approximately 10mm of k-wire broke off inside the patient as the surgeon was drilling it.The wire was left inside the patient's bone.There were no adverse consequences to the patient as a result of this event.

• Brand Name: DRILL-TIP RECON K-WIRE IMN INSTRUMENTS Ø3.2X400MM
• 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: sharon rivas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 12579900
• Report Number: 0009610622-2021-00730
• Device Sequence Number: 3487780
• Product Code: LXH
• UDI-Device Identifier: 07613327361698
• UDI-Public: 07613327361698
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/13/2022

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: 2351-3240S
• Device Catalogue Number: 23513240S
• Device Lot Number: K0CAB13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 10/05/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2020
• 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 Sex: Unknown