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	01/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the end user reported that gamma3 nail can no longer be disconnected from the nail holding screw and the aiming device." completely had to be removed, new implant had to be placed freehand and the procedure took longer, leading to an unknown surgical delay.
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: "the end user reported that gamma3 nail can no longer be disconnected from the nail holding screw and the aiming device." completely had to be removed, new implant had to be placed freehand and the procedure took longer, leading to an unknown surgical delay.
Additional Manufacturer Narrative
Please note the correction to h6 health impact codes.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 received device came back jammed/assembled which was unblocked later.The device shows signs of usage, but no visible major damage was observed which can affect the functionality of the device.However dried blood was observed inside and outside on the surface of the screw.Post-decontamination and after cleaning dried blood, a pre-surgical test was conducted for the returned devices.Upon inspection, the devices were functionally ok.Assembling and disassembling of the nail-holding screw can be easily done through the target device with the nail without any resistance.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 investigation, the root cause of the issue is most likely user related.The devices shows the appearance of dried blood residual on their surfaces, which potentially caused overtightening of the nail in between the interface of the nail, target device 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: 16280458
• Report Number: 0009610622-2023-00020
• Device Sequence Number: 12392729
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 03/28/2023

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: KSS13N227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2023
• Supplement Date Received by Manufacturer: 02/28/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2013
• 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 Sex: Unknown