MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TARGET DEVICE, G3 PLUS GAMMA3; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-1010
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that the c clip at the tip of the gamma 3+ targeting arm where the nail attaches became dislodged in the patient's wound.It was further reported that the c clip was seen on the final x-ray.Surgeon had to retrieve the c clip from the patient¿s wound.Surgical delay: less than 1 minute.
Event or Problem Description
It was reported that the c clip at the tip of the gamma 3+ targeting arm where the nail attaches became dislodged in the patient's wound.It was further reported that the c clip was seen on the final x-ray.Surgeon had to retrieve the c clip from the patient¿s wound.Surgical delay: less than 1 minute.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: the received target device, g3 plus gamma3® shows traces of a long and intense use identified by the general appearance of the surfaces and by the appearance of the white printings, which turned from white to fawn [an indication for high sterilization cycles].The c-ring at the reception for the nail was found to be missing.The c-ring was not made available for evaluation and thus, a physical evaluation of the c-ring impossible.Due to missing c-ring, it was not possible to determine if c-ring was deformed or damaged.It cannot be excluded that the missing c-ring was detached prior to the surgery during the re-processing.During detachment the ring may have been deformed and / or may have been attached in unintended mode which may have affected the secure fit of the c-ring [loosening].The c-ring [clamping ring] is a feature to ease nail assembly ¿ but the function is still given without the c-ring.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by improper handling.

• Brand Name: TARGET DEVICE, G3 PLUS 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
• MDR Report Key: 10254110
• Report Number: 0009610622-2020-00314
• Device Sequence Number: 2780028
• Product Code: LXH
• UDI-Device Identifier: 07613154972173
• UDI-Public: 07613154972173
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: 1320-1010
• Device Catalogue Number: 13201010
• Device Lot Number: KME912242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1