MAUDE Adverse Event Report: STRYKER TRAUMA KIEL CLOSED TUBE CLIP GAMMA3®; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0125
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "we noticed during packaging that the tube was broken, this did not happen during an operation so there was no patient impact.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation, and matches the alleged failure.The device inspection revealed the following: the device received was found to be broken along the edge around distal portion.Overall, the device showed signs of significant usage.A significant crack was observed on the arm.Absence of any plastic deformation indicates the breakage to be brittle, most likely due to a sudden impact load.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.Based on investigation, the root cause was attributed to a user related issue.The manner of breakage indicates the device was impacted/mishandled.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "we noticed during packaging that the tube was broken, this did not happen during an operation so there was no patient impact.".

• Brand Name: CLOSED TUBE CLIP GAMMA3®
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 15100154
• Report Number: 0009610622-2022-00341
• Device Sequence Number: 4213796
• Product Code: LXH
• UDI-Device Identifier: 04546540508003
• UDI-Public: 04546540508003
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2022

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: 1320-0125
• Device Catalogue Number: 13200125
• Device Lot Number: K03F2CA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 07/25/2022
• Supplement Report FDA Received Date: 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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