MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X400MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3530-1400S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported a broken gamma nail they are revising soon.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
The customer reported a broken gamma nail they are revising soon.Update: additionally, non union in patient was reported.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.Device inspection revealed the following: the received nail is found to be completely broken in the webs of the proximal lag screw hole.The fracture appears to have originated from the posterior web in a fatigue manner, as evident by the lines of rest/waves.The anterior web shows signs of instantaneous fracture which is a result of sudden loading after the breakage of the posterior web.Miss-drilling marks are also evident majorly on the anterior web, running from lateral entrance to the medial through the bore.Very slight miss-drilling marks appear on the posterior web.The effect of miss-drilling on the breakage in this case cannot be quantified.On the medial side of the distal portion of the nail, the bearing point shows signs of permanent deformation indicating towards overloading 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.The instruction for use states that ¿these devices can break when subjected to the increased loading associated with delayed unions and/or non-unions.Internal fixation devices are load sharing devices which are intended to hold fractured bone surfaces in apposition to facilitate healing.If healing is delayed or does not occur, the appliance may eventually break due to metal fatigue.Loads on the device produced by load bearing and the patient¿s activity level will dictate the longevity of the device.¿ based on the investigation and the available facts, the root cause of the issue is majorly attributed to patient related factors.The fracture area of the nail exhibits a fatigue fracture and a plastically deformed medial side which indicates towards constant overloading in a cyclic manner.The overloading can be explained by the non-union of fracture site in the patient, as received through the additional information.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3® Ø11X400MM X 130°
• 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: 13102353
• Report Number: 0009610622-2021-00831
• Device Sequence Number: 4717962
• Product Code: HSB
• UDI-Device Identifier: 07613252274452
• UDI-Public: 07613252274452
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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 Expiration Date: 08/31/2025
• Device Model Number: 3530-1400S
• Device Catalogue Number: 35301400S
• Device Lot Number: K0543FB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 12/28/2021
• Supplement Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2020
• 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 Sex: Unknown