MAUDE Adverse Event Report: STRYKER TRAUMA KIEL TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM X 125; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3125-0170S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/13/2020
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
As reported: first surgery in (b)(6) 2019.The patient suddenly felt pain, so the patient visited the clinic on (b)(6).Image diagnosis revealed fracture of the nail due to false joint.(b)(6): re-operated to change to long nails.Upon removal, the nail was partially broken in front of the lag screw hole.
Additional 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.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 1 web after an implantation period of approx.6,5 months.Intra-operative material damage had significantly weakened the material in a highly stress applied area creating an incipient crack.After surgery, a remaining gap in the bone fracture site and additional high axial load application may have contributed to the event.High load application was introduced by the patient.Intra-operative material damage and a remaining bone fracture gap were regarded being user related.In case substantive information becomes available we reserve the right to reopen the investigation with root cause assessment.
Event or Problem Description
As reported: first surgery in (b)(6) 2019.The patient suddenly felt pain, so the patient visited the clinic on (b)(6).Image diagnosis revealed fracture of the nail due to false joint.(b)(6): re-operated to change to long nails.Upon removal, the nail was partially broken in front of the lag screw hole.

• Brand Name: TROCHANTERIC NAIL KIT, TI GAMMA3 10X170MM 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; DE D-24232
• MDR Report Key: 10139598
• Report Number: 0009610622-2020-00282
• Device Sequence Number: 3361517
• Product Code: HSB
• UDI-Device Identifier: 04546540375063
• UDI-Public: 04546540375063
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2020

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 Model Number: 3125-0170S
• Device Catalogue Number: 31250170S
• Device Lot Number: K037153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/15/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 06/10/2020
• Supplement Report FDA Received Date: 09/02/2020
• 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: 83 YR
• Patient Weight: 72