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	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of the investigation any additional information will be communicated in a supplemental report.
Event or Problem Description
It was reported that the surgeon was over reaming for the proximal screw placement when the treaded guide pin broke (cat# 1210-645s).The treads got stuck in the soft tissue and could not be retrieved.The tip of the guide wire left in the patient is approximately 3mm.The patient had a gamma nail that was a non-union.The gamma nail was not removed.The surgery was a repair of non-union right hip.
Event or Problem Description
It was reported that the surgeon was over reaming for the proximal screw placement when the threaded guide pin broke (cat# 1210-645s).The threads got stuck in the soft tissue and could not be retrieved.The tip of the guide wire left in the patient is approximately 3mm.The patient had a gamma nail that was a non-union; the gamma nail was not removed.The surgery was a repair of non-union right hip.
Additional Manufacturer Narrative
H6 clinical signs code has been updated.The reported event could be confirmed, since physical evaluation revealed a broken off tip.The threaded tip of the received k-wire is broken off; it broke approx.After the last winding.The breakage surface of the broken thread indicates that the k-wire tip broke in a brittle fracture due to bending and/or torsion overload (i.E.Hitting the nail surface).Furthermore, x-ray control must be done during k-wire insertion to avoid misalignments and hitting the nail.X-rays were requested but not provided and thus, a medical statement deemed dispensable in this case.The broken off tip was not returned; according to event description ¿surgeon was over reaming for the proximal screw placement when the treaded guide pin broke¿ and to further details received ¿the tip of the guide wire left in the patient is ~3mm.¿.A previous case was evaluated by a medical expert.According to him the material of the k-wire is non-critical to the patient and shall remain until the bone is healed.A removal shall only be done in case no significant collateral damage will occur.However, it lies in the responsibility of the treating surgeon to leave or to remove the broken off part.With regard to the available information and due to above facts a non-conformance of the product was not identified.The case is rather related to intra-operative procedure of the user.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.No indications of material, manufacturing or design related problems were found during the investigation.In case substantive information will become available in future that suggests otherwise we reserve the right to reopen the case.

• 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: 11942589
• Report Number: 0009610622-2021-00534
• Device Sequence Number: 4548207
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 09/17/2021

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: 12/31/2024
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K0CDABE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 77