MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X300MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-1300S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.H3 other text : device disposition unknown.
Event or Problem Description
As reported: "breakage of the nail.A revision will probably have to be performed.".
Event or Problem Description
As reported: "breakage of the nail.A revision will probably have to be performed.".
Additional Manufacturer Narrative
Please note correction to d3 (manufacturer entity) and d9/h3.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 nail is completely broken in the webs of the proximal lag screw hole.Significant drill marks, with chamfer-like material removal, were observed on the lateral side of the proximal and distal segment of the broken nail and progressing toward the medial side.The mis-drilling had extended along the posterior web.The drill marks were generated by a deviated lag screw step drill which had created the starting point of the fracture (notching effect) at the lateral edge due to over lying stresses.The lag screw bearing point on the medial side at the distal end shows deformation which is from the high compressive load.This deformation indicates that the nail was exposed to continuous high loads over a longer period of time.The breakage pattern resembles a fatigue breakage of 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 and available information, the root cause of the failure is most likely user -related.The appearance of mis-drilling marks indicates that the nail was damaged intra-operatively which may have led to the weakening of the nail initially.Along with that the simultaneous overloading on the whole construct ultimately led to the breakage of the nail in a fatigue manner.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X300MM X 125°
• 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: 16820690
• Report Number: 0009610622-2023-00135
• Device Sequence Number: 20586603
• Product Code: HSB
• UDI-Device Identifier: 07613252273806
• UDI-Public: 07613252273806
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K034002
• 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): 07/12/2023

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: 3425-1300S
• Device Catalogue Number: 34251300S
• Device Lot Number: K07D78C
• 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: 03/30/2023
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2022
• 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: 89 YR
• Patient Sex: Female