MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LAG SCREW, TI GAMMA3® Ø10.5X90MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3060-0090S
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It has been reported the assembly of the gamma nail does not coincide with the lag screw: when trying to insert the cephalic screw, excessive force had to be used and it was noticeable that it did not slide well inside the nail.We checked that everything was well connected, that it was the guide that had to be, the angulation that it had to be, everything verifiable.We ended up removing everything, disassembled and reassembled outside and testing outside, it continued to rub against the cephalic screw when passing inside of the nail.In the end we put a nail and a new screw.The procedure was delayed by 60 min.
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It has been reported the assembly of the gamma nail does not coincide with the lag screw: when trying to insert the cephalic screw, excessive force had to be used and it was noticeable that it did not slide well inside the nail.We checked that everything was well connected, that it was the guide that had to be, the angulation that it had to be, everything verifiable.We ended up removing everything, disassembled and reassembled outside and testing outside, it continued to rub against the cephalic screw when passing inside of the nail.In the end we put a nail and a new screw.The procedure was delayed by 60 min.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device was found to be fully functional and conforming to specifications.The device inspection revealed the following the received lag screw has visible scratch marks which can be caused by forceful insertion, and which can be also evident on the nail as stress marks are visible in the lag screw insertion hole.The scratch marks are visible on the proximal end of the screw.Functional test was performed with the reported lag screw and nail, in which no insertion problem was observed, and the lag screw could be locked as required.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Based on the investigation, the root cause was attributed to a user related issue since the device is found to be fully functional during the inspection.If any additional information is provided, the investigation will be reassessed.

• Brand Name: LAG SCREW, TI GAMMA3® Ø10.5X90MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 13620279
• Report Number: 0009610622-2022-00075
• Device Sequence Number: 19925762
• Product Code: HSB
• UDI-Device Identifier: 04546540374929
• UDI-Public: 04546540374929
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 3060-0090S
• Device Catalogue Number: 30600090S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown