MAUDE Adverse Event Report: STRYKER TRAUMA KIEL K-WIRE GAMMA Ø3,2X450 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1210-6450S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported the following issue: "intervention for a long gamma nail.When using the kirshner wire, the end of the wire broke off in the nail.The nail had to be removed, the broken end had to be removed and then a new wire had to be used.This led to an extension of the intervention (3 minutes of delay)".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned, and matches the alleged failure.The device inspection revealed the following: the visual inspection of the received k-wire confirms the breakage, and breakage cross-section indicates towards a cup-cone fracture formation which is caused due to torsional shear (twisting).The tip of the wire is heavily damaged, and there is nothing left from the original shape of the tip.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in slightly off from the acceptable values but considering the breakage, diameter, and surface of the returned device, the value is deemed acceptable.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.The instructions for use states that ¿during the procedure, repeatedly check that the connections between the instruments or between implants and instruments required for the precise positioning and fixing are secure.¿ based on the investigation the root cause was attributed to a user related issue.The nature of breakage of the k-wire is because of torsional shear applied by the user.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
Customer reported the following issue: "intervention for a long gamma nail.When using the kirshner wire, the end of the wire broke off in the nail.The nail had to be removed, the broken end had to be removed and then a new wire had to be used.This led to an extension of the intervention (3 minutes of delay)".

• Brand Name: K-WIRE GAMMA Ø3,2X450 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
• 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: 12810739
• Report Number: 0009610622-2021-00792
• Device Sequence Number: 4757201
• Product Code: LXH
• UDI-Device Identifier: 04546540175366
• UDI-Public: 04546540175366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2022

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 Expiration Date: 07/31/2026
• Device Model Number: 1210-6450S
• Device Catalogue Number: 12106450S
• Device Lot Number: K066213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 02/24/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2021
• 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 Sex: Unknown