MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X400MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3525-1400S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/20/2020
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 that the gamma nail had broken where the neck of the nail interfaces with the lag screw.The nail was implanted a few months ago.The broken nail and implants were removed and revised with 13mm gamm.
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 in the webs of the proximal lag screw hole.The appearance of the breakage surface of the anterior web suggests that the nail breakage had its origin in this area.Severe drill marks were found at the lateral entrance of the proximal through hole at the anterior web; they progress through the bore towards medial.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge of the anterior web.The fracture pattern resembles a fatigue fracture, evident by appearance of lines of rest/ waves in both the anterior and posterior web.Starting from the anterior web with an incipient crack at the lateral edge, the breakage progressed through the cross section.Gradually, alongside the anterior web, the posterior web also started getting fatigued and broke ultimately.Severe deformation (plastic deformation) was also observed on the medial side of the through hole at the bearing point of the lag screw, which indicates towards high loading on the nail.Similar features (plastic deformation) were observed on the edges of both the webs, all indicating towards high cyclic loading.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, it can be said that the root cause of the breakage is both user and patient related.Presence of drill marks on the nail indicates towards a user induced cause of failure, while severe deformation at bearing point of lag screw indicates towards high loading (a likelihood of a non-union is also there), which is attributed to a patient related issue.But due to unavailability of critical patient¿s record at the time of evaluation and the fact that there was an intra-op damage of nail, the root cause is determined to be user related, predominantly.The op-tech clearly provides a warning to the user: ¿warning: in the event the nail is damaged during lag screw reaming, the fatigue strength of the implant may be reduced, which may cause nail to fracture.¿ the ifu clearly specifies: ¿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.
Event or Problem Description
The customer reported that the gamma nail had broken where the neck of the nail interfaces with the lag screw.The nail was implanted a few months ago.The broken nail and implants were removed and revised with 13mm gamm.

• Brand Name: LONG NAIL KIT R1.5, TI, LEFT GAMMA3 11X400MM X 125
• 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: 10840210
• Report Number: 0009610622-2020-00707
• Device Sequence Number: 2960216
• Product Code: HSB
• UDI-Device Identifier: 07613252274315
• UDI-Public: 07613252274315
• 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 Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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: 02/28/2025
• Device Model Number: 3525-1400S
• Device Catalogue Number: 35251400S
• Device Lot Number: K04FE49
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 01/13/2021
• 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: 79 YR