MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA 3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1210-6450S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device is not available; disposed by hospital.
Event or Problem Description
As reported: "i was made aware today that the tip of a gamma guide wire item # 1210-6450s (lot# k0e3549) broke off inside the greater troch region while they were attempting to get the starting point for an alpha gt nail on (b)(6) 2020.They declined to remove the tip of the wire because it would have caused more damage to do so.The procedure continued and was completed without further issue or surgical delay.".
Event or Problem Description
As reported: "i was made aware today that the tip of a gamma guide wire item # 1210-6450s (lot# k0e3549) broke off inside the greater troch region while they were attempting to get the starting point for an alpha gt nail on (b)(6) 2020.They declined to remove the tip of the wire because it would have caused more damage to do so.The procedure continued and was completed without further issue or surgical delay.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the xray was provided that matches the alleged failure mode.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 in order to determine the root cause of the complaint event.However, in general breakage of k-wire tip could be due to handling failure or mechanical overstressing.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: K-WIRE GAMMA 3,2X450 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
• MDR Report Key: 11189697
• Report Number: 0009610622-2021-00236
• Device Sequence Number: 14321883
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2021

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 Expiration Date: 01/31/2025
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K0E3549
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1