MAUDE Adverse Event Report: STRYKER TRAUMA KIEL FEMORAL NAIL, A/R T2 FEMUR 10X360 MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	1825-1036S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The customer reported a broken nail.Patient arrives at the clinic with a broken nail and a broken distal screw.No trauma apparent, no further histological findings, non-union, no calcification visible in the fracture gap.Revision surgery with the "sliding nail" (company intercus) slide 12mm.
Event or Problem Description
The customer reported a broken nail.Patient arrives at the clinic with a broken nail and a broken distal screw.No trauma apparent, no further histological findings, non-union, no calcification visible in the fracture gap.Revision surgery with the "sliding nail" (company intercus) slide 12mm.
Additional Manufacturer Narrative
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 from the center region.The fracture pattern resembles a fatigue fracture (evident by appearance of shiny surface).This just weakened the nail.The fracture pattern also suggests that after a while the breakage was abrupt and instantaneous with material chip off from the side.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 investigation, the root cause was attributed to a patient factor.The failure was caused by patient factor (such as bone quality, activity, non-union or high load application) resulted in fatigue fracture, which can be correlated by the communication of non-union, evidently can be confirmed based on implant & explant dates.¿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.¿ if any further information is provided, the complaint report will be updated.

• Brand Name: FEMORAL NAIL, A/R T2 FEMUR 10X360 MM
• 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
• MDR Report Key: 10891743
• Report Number: 0009610622-2020-00770
• Device Sequence Number: 3005511
• Product Code: HSB
• UDI-Device Identifier: 04546540199515
• UDI-Public: 04546540199515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K010801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2021

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: 01/31/2023
• Device Model Number: 1825-1036S
• Device Catalogue Number: 18251036S
• Device Lot Number: K03268A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Initial Date Received by Manufacturer: 10/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR