MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 3125-1180S

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Implant Pain (4561)

Event Date 01/28/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

"the customer reported that : "fracture of the osteosynthesis material at 4 months of surgical management.The patient (b)(6) describes the occurrence of a sudden pain that prompted an x-ray that revealed a fracture of the proximal part of the short gamma nail.Doctor notes a migration of the osteosynthesis material.Programming of a revision surgery with removal of the defective nail and replacement by a longer nail."".

Manufacturer Narrative

The reported event was confirmed.The review of manufacturing documents revealed no deviation in the manufacturing process.Required material properties had been confirmed prior to manufacturing.No nc/capa had been filed for the item in question.Potential implant breakage had been considered in the risk management file with appropriate values not having been exceeded by this case.The labelling already informs about that a temporary implant requires sufficient bone consolidation in order to relieve the nail during the implantation period.The labelling also points out potential reasons for insufficient bone healing ¿ e.G.But not limited to osteoporosis and/or diabetes and points out that an intra-operatively damaged implant is at risk for breakage.The labelling points out that product damage must be avoided.No indications of material, manufacturing or design related problems were found during the investigation.In the case presented a gamma3 trochanteric nail had broken in the webs of the drill hole for the lag screw after an implantation period of allegedly 4 months.The breakage pattern confirmed a fatigue fracture.Nail breakage had been caused by high axial load application and was contributed by overlaying stress values in the contact areas of nail and lag screw.Potential risks for implant breakage are referenced in the labelling.With available information the cause of the event was regarded as patient related contributed by interaction of implants depending on their position.In case substantive information becomes available we reserve the right to reopen the investigation with root cause assessment.

Event Description

"the customer reported that : "fracture of the osteosynthesis material at 4 months of surgical management.The patient (85 years old) describes the occurrence of a sudden pain that prompted an x-ray that revealed a fracture of the proximal part of the short gamma nail.Doctor notes a migration of the osteosynthesis material.Programming of a revision surgery with removal of the defective nail and replacement by a longer nail."".

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 11X180MM 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: 11376310
• MDR Text Key: 233453141
• Report Number: 0009610622-2021-00307
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04546540375070
• UDI-Public: 04546540375070
• 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: 05/04/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 3125-1180S
• Device Catalogue Number: 31251180S
• Device Lot Number: K0DE627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 01/28/2021
• Initial Date FDA Received: 02/24/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR