MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1200S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

Upon completion of investigation, additional information will be provided in a supplemental report.

Event Description

The customer reports a broken gamma nail.Revision had to be performed.

Event Description

The customer reports a broken gamma nail.Revision had to be performed.

Manufacturer Narrative

Evaluation revealed the received trochanteric nail kit, ti gamma3® ø11x200mm x 125° to be the primary product.The other implants received were considered to be concomitant products as they did not contribute to the event reported.Deficiency in material or manufacturing was not found.Dimensional examination revealed no deviations in the relevant undamaged areas of the nail.The received nail was completely broken in the webs of the proximal drill hole for the lag screw.According to the damage and the evidence of the breakage surfaces the nail broke in a fatigue manner after an unknown implantation period.Mechanical damage as well as scuffed off coating inside the proximal drill hole of the right web - had been caused by the contact with a deviated step drill.Such damage may cause additional notch effects.According to the appearance of the breakage surfaces of the right web at lateral it was suggested that the nail breakage had its origin in this area.Starting with an incipient crack the breakage progressed through the cross section and ended in a residual fracture at medial.The breakage in the left web followed most likely with delay in a much quicker way.A nail will be subject of a fatigue fracture if the stresses on the implant are too high or not considerably reduced during the period of implantation.The affected implant is designed to withstand the normal loads during the implantation period, i.E.The implant must neither be exposed to peak loads nor to continuous stresses.Another prerequisite for a successful supply is undisturbed, normal bone healing.This state must be achieved within a medically recognized period (confirmed by scientific analysis about 6 months) in such way, that the bone strength allows significantly increasing discharge of the time-fixed implant material.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complication.As no x-ray documentation and no operation reports were available, a medical review was not possible.It could not be determined whether the use of the nail had the correct indication nor could be determined if the implants had been placed according to the anatomical requirements.Regarding the outstanding patient data (e.G.Potential diseases) it could not be determined if the patient conditions were adequate for the used implant.Based on the above the nail breakage was not linked to a deficiency of the device, but was rather patient related contributed by the intra-operative damage of the nail by a deviated step drill resulting in a significant weakening of the nail in the area of the lateral edge of the right web.Review of capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 11X200MM X 125
• Type of Device: 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: 10436523
• MDR Text Key: 203833352
• Report Number: 0009610622-2020-00485
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375087
• UDI-Public: 04546540375087
• Combination Product (y/n): N
• PMA/PMN Number: K034002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 3125-1200S
• Device Catalogue Number: 31251200S
• Device Lot Number: K0C6BEE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2020
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention