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

Model Number	1320-0090
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2020
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
During the drilling for the shs, the drill bit ran onto the nail.The adjustments on the insertion handle were reportedly correct and the k-wire was reportedly correctly positioned subchondrally.The nail holding screw was then difficult to remove from the nail.Replacement was available.Surgical delay of 10min.Not longer.
Event or Problem Description
During the drilling for the shs, the drill bit ran onto the nail.The adjustments on the insertion handle were reportedly correct and the k-wire was reportedly correctly positioned subchondrally.The nail holding screw was then difficult to remove from the nail.Replacement was available.Surgical delay of 10min.Not longer.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.During simulation of pre-op check the returned devices could be assembled and disassembled without excessive force as intended.The subject of the reported event could not be reproduced.Signs of seizing / fretting corrosion were not found on the items.The threads of the nhs are in good condition.Although a real root cause could not be determined the alleged event is most likely caused due to a sub-optimal intraoperative procedure, which is supported by the signs of damage at the proximal bore of the nail and has to be classified as user-customer-user error.Pre-supposing that functionality was confirmed by pre-operative check performed, which is required per ifu, it was concluded that the event was mainly based in the medical procedure.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.

• 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: 10130660
• Report Number: 0009610622-2020-00280
• Device Sequence Number: 1847757
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: KSS138670
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1