MAUDE Adverse Event Report: STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø11X400 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	18451140S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
The nail broke in the distal lug screw hole and was replaced with a 15mm recon nail.Patient had to come back for a revision surgery.
Event or Problem Description
The nail broke in the distal lug screw hole and was replaced with a 15mm recon nail.Patient had to come back for a revision surgery.
Additional Manufacturer Narrative
The reported event could be confirmed.Based on investigation the nail breakage is not linked to a deficiency of the device but is rather considered patient related contributed by an intra-operative damage of the nail by a deviated stepdrill for lag screw, which most likely had created the starting point of the fracture [notching effect].Failures in material or manufacturing of the affected nail returned were not found.Dimensional examination revealed no deviations in the relevant undamaged areas of the device in question.The drill marks were generated by a deviated stepdrill which most likely had created the starting point of the fracture [notching effect] at the lateral edge of the posterior web.Axial load may have contributed to the progress of the incipient crack at lateral.The affected nail 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.In case that such a situation does not occur, exceeding of the fatigue strength is to be expected and thus quite predictable complications.According to the event description: ¿the nail broke and we replaced it with a 15mm recon nail.Patient had to come back for a revision surgery¿ which could be a hint for a delayed healing.Axial overload had led to continuous stresses and a significant weakening of the nail in the area of the distal of the proximal drill holes for the lag screws, followed by the fatigue fracture after an implantation duration of 16 weeks.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Intra-operative implant damage and postoperative loads are listed as adverse effects in the ifu.

• Brand Name: RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø11X400 MM 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
• MDR Report Key: 8434677
• Report Number: 0009610622-2019-00114
• Device Sequence Number: 239319
• Product Code: HSB
• UDI-Device Identifier: 04546540412690
• UDI-Public: 04546540412690
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 05/31/2022
• Device Catalogue Number: 18451140S
• Device Lot Number: K0A7802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 06/03/2019
• 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: 67 YR
• Patient Weight: 91