MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW GAMMA3 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2020
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
Customer reported that : "the gamma nail broke when it was inserted into the patient.The nail locking nut or screw on the nail holder broke in the nail.The device could be removed and replaced with a new one with a new insertion aid." additionally reported: this occurred during primary implantation, no debris reported, it was the "nail retaining screw" that broke off, "no more than a few minutes" of delay.
Event or Problem Description
Customer reported that : "the gamma nail broke when it was inserted into the patient.The nail locking nut or screw on the nail holder broke in the nail.The device could be removed and replaced with a new one with a new insertion aid." additionally reported: - this occurred during primary implantation.- no debris reported.- it was the "nail retaining screw" that broke off.- "no more than a few minutes" of delay.
Additional Manufacturer Narrative
The reported event that the nail holding screw gamma3 broke in the nail could be confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the nail holding screw was found to be broken.There is a clear breakage visible around the distal region of the nail holding screw.Apart from this, the threads at the distal end of the nail holding screw are also damaged.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 instructs user that: ¿the stryker "instructions for cleaning, sterilization, inspection and maintenance" help to determine whether an instrument is in good condition or must be replaced due to excessive wear or obvious defects.¿ based on investigation, the root cause was attributed to a normal wear related issue.The device was manufactured in 2006, so it can be said that it has performed it¿s function in the previous surgeries as intended without any reported failure.Since it has been long in use, thus a normal weakened structural integrity due to repeated reprocessing cycles is considered possible.If any further information is provided, the complaint report will be updated.

• Brand Name: NAIL HOLDING SCREW GAMMA3 8X35MM
• 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: 10423159
• Report Number: 0009610622-2020-00480
• Device Sequence Number: 3671972
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

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: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: K859203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1