MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	18060370
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt.Multiple attempts with no success.A second nail was opened and the nail successfully engaged with the holding bolt.Two minute surgical delay reported.No adverse consequences were reported.
Event or Problem Description
It was reported that, during a tibial nail procedure, when it came time to attach the nail to the holding bolt, the threads inside the nail would not engage with the holding bolt.Multiple attempts with no success.A second nail was opened and the nail successfully engaged with the holding bolt.Two minute surgical delay reported.No adverse consequences were reported.
Additional Manufacturer Narrative
Investigation determined that this device is concomitant and did not contribute to the reported failure.Upon functional inspection of the two devices, it was found that the connection between the reported nail and the reported nail holding screw was not possible.There was no sign of damage on the nail holding screw.However, threads of the nail were found damaged.Upon further evaluation, when the reported nail holding screw was used with a sample nail, the connection between them was found perfect.This suggests that the nail holding screw was not the immediate cause, but the nail was.

• Brand Name: NAIL HOLDING SCREW, TIBIA T2 TIBIA 10 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32
• MDR Report Key: 8483107
• Report Number: 0009610622-2019-00144
• Device Sequence Number: 13846980
• Product Code: LXH
• UDI-Device Identifier: 04546540196484
• UDI-Public: 04546540196484
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

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 Catalogue Number: 18060370
• Device Lot Number: K807992
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1