MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3520-1340S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/09/2023
Type of Reportable Event	Serious Injury
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: "fracture of the gamma 3 nail implanted on (b)(6) 2022 long without accidental fall event.Further surgery on (b)(6) 2023 with removal of fragments and re-osteosynthesis.".
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity).The received pictures and x-rays were reviewed and it can be confirmed that the nail is broken apart at the lag screw hole.The quality of the pictures is too low to make any statement about the breakage pattern.A device inspection was not possible since the affected device was not returned, therefore no further evaluation is possible.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.The complaint was forwarded to medical affairs for review with following feedback: "the fracture morphology shows a pertrochanteric fracture of the femur with a large fragment of the lesser trochanter, which is clearly displaced cranially.The postoperative x-ray shows a very good reposition with correctly inserted foreign material.The trochanteric fragment was not refixed.The unfavorable fracture morphology and presumably also the medial instability caused by the not repositioned trochanter fragment may have contributed to the failure.In addition, the parkinson's diagnosis is another patient-based factor that may have contributed to a prolonged healing due to the ataxic gait pattern.However, there are no clear recommendations in this regard (the corresponding dgou (deutsche gesellschaft für orthopädie und unfallchirurgie e.V.) guideline is currently being revised)." no product related issue could be detected.The provided information indicates that multiple not implant related factors did contribute to the reported event, but without evaluation of the affected nail no exact root cause can be defined.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "fracture of the gamma 3 nail implanted on (b)(6) 2022 long without accidental fall event.Further surgery on (b)(6) 2023 with removal of fragments and re-osteosynthesis.".

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X340MM X 120°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 16943309
• Report Number: 0009610622-2023-00154
• Device Sequence Number: 3466746
• Product Code: HSB
• UDI-Device Identifier: 07613252274124
• UDI-Public: 07613252274124
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 3520-1340S
• Device Catalogue Number: 35201340S
• Device Lot Number: K031ED2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 55 KG