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 Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2022
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 discarded.
Event or Problem Description
As reported: "when inserting k-wire, the tip broke off about 3mm and remained in the bone.The surgeon tried to remove it, but could not.".
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device discarded.
Event or Problem Description
As reported: "when inserting k-wire, the tip broke off about 3mm and remained in the bone.The surgeon tried to remove it, but could not.".
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no evidence was provided.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.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 information as well as the affected device must be returned to determine the exact root cause of the event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "when inserting k-wire, the tip broke off about 3mm and remained in the bone.The surgeon tried to remove it, but could not.".

• 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: marilyne chaumont ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13509864
• Report Number: 0009610622-2022-00047
• Device Sequence Number: 19849469
• Product Code: LXH
• UDI-Device Identifier: 07613327361698
• UDI-Public: 07613327361698
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: K0D6D59
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2021
• 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: 68 YR
• Patient Sex: Male