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

Model Number	1320-0090
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
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: "the doctor was performing an intramedullary gamma nail on the patient's right side.During the impaction of the nail the locking bolt beacon cold welded to the nail and was unable to separate the targeted from the nail.A new targeter tray was opened with another locking bolt as well as a new nail.The procedure was complete without further incident".
Additional Manufacturer Narrative
The reported event could be confirmed, since the devices could not be disassembled as designed.The device inspection revealed the following: the visual inspection of the target device has shown that there is a deformation at the edge of the nail holding screw bore visible.Above the deformation are strong stress marks visible, the marks were caused during the forcible removal of the holding screw during the investigation.The devices were received in assembled condition, the holding screw was jammed as complained.It was possible to disassemble the devices during the evaluation by applying high forces.The testing has shown that the complained malfunction was clearly caused by a deformation at the holding screw.At the deformation was the material of the edge pushed out, this material did get stuck at the edge of the targeting device and made finally the removal of the screw impossible.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 an an excessive, inappropriate hit with a hammer onto the nail holding screw while the devices were assembled.In this relation we would like to point out the instructions for use with following statement: do not hit instruments unless they are specifically intended for impaction.Never hit targeting devices or elastosil handles other than those with an integrated strike plate.
Event or Problem Description
It was reported: "the doctor was performing an intramedullary gamma nail on the patient's right side.During the impaction of the nail the locking bolt beacon cold welded to the nail and was unable to separate the targeted from the nail.A new targeter tray was opened with another locking bolt as well as a new nail.The procedure was complete without further incident.".

• 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: 11899082
• Report Number: 0009610622-2021-00532
• Device Sequence Number: 1321079
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/09/2021

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: No Information
• Device Model Number: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: KSS167H18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 09/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR