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

Model Number	1320-0090
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "we hereby inform you that yesterday (b)(6) 2022, at 7.45 pm, at the (b)(6) clinic, a gamma nail surgery took place.The procedure was carried out correctly from the early stages of assembly up to the implantation of the distal screw.Everything as usual.When it was time to unscrew the screw that locks the nail to the carbon mask, however, it showed no signs of yielding even by a millimeter.Consequently, the operator had to remove the nail from the patient, hoping that on the operating table it would be easier to remove it from the mask.Not even with the use of a vice were they able to move the screw.At that point the agent, in urgency and to complete the intervention, was forced to take a gamma 3 instrumentation in storage at the aurelia hospital to take it to paideia, where it was sterilized and then, with about two hours of delay from the practice, the operator has finally finished the nail.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "we hereby inform you that yesterday (b)(6) 2022, at 7.45 pm, at the (b)(6), a gamma nail surgery took place.The procedure was carried out correctly from the early stages of assembly up to the implantation of the distal screw.Everything as usual.When it was time to unscrew the screw that locks the nail to the carbon mask, however, it showed no signs of yielding even by a millimeter.Consequently, the operator had to remove the nail from the patient, hoping that on the operating table it would be easier to remove it from the mask.Not even with the use of a vice were they able to move the screw.At that point the agent, in urgency and to complete the intervention, was forced to take a gamma 3 instrumentation in storage at the aurelia hospital to take it to paideia, where it was sterilized and then, with about two hours of delay from the practice, the operator has finally finished the nail.".
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the inner surface of the returned nail holding screw is damaged possibly would have been caused in an attempt to disassemble.The remnants of dried blood can be observed in the threads indicating the blood percolated in the assembly.The received assembly of devices could not be disassembled as the nail holding screw was found to be stuck.Post decontamination, pre-surgical test was conducted for the returned assembly.Upon inspection, the devices were functionally ok.The nail holding screw could be easily advanced into the target device and the nail.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.Based on the above investigation, the root cause of the issue is most likely user related.The device shows appearance of blood residual on its surfaces, which potentially caused overtightening of the nail in between the interface of the nail and the screw.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
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14473871
• Report Number: 0009610622-2022-00201
• Device Sequence Number: 4504223
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2022

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: KSS217112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 09/05/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male