MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X340MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	32250340S
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/08/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It is reported by the surgeon of the hospital, that the g3 nail broke.Send request to sales rep to get further information.
Additional Manufacturer Narrative
The evaluation revealed the broken gamma3 long nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail returned was documented as faultless prior to distribution.During investigation no material, design or manufacturing related issues were found.The nail was found drill marked within the anterior bridge of the proximal lag screw hole; a part of the bridge material is completely abraded at lateral.The anterior breakage line was found within the drill marked area.This misdrilling effect did weak the anterior bridge significantly and caused a notching effect on the lateral side that favours the nail breakage.Misdrilling could occur in case the target device was pre-damaged, instruments were not assembled correctly or bending forces were applied to the drill and/or target device during drilling.The operative technique includes that the target device shall be checked prior to every surgery.Smooth lines of rest are visible on the anterior bridge breakage surface; the bridge broke step by step.The lines of rest run from lateral towards medial.These lines of rest indicate (in combination with the found drill marks), that the nail breakage started at the anterior bridge at lateral.After the anterior bridge was full or main partly broken, the posterior bridge followed first step by step and finally spontaneous.The nail broke due to a fatigue fracture.Bearing points on the distal part of the proximal nail hole indicate that heavy loads were applied postoperatively to the implants; these loads did most likely also contribute to the nail breakage.The customer reported that a pseudoarthrosis was detected after approx.6 months.Furthermore, the patient height is unknown; obesity cannot be excluded.The available information was evaluated by a medical expert.According to him the fracture is an instable subtrochanteric spiral fracture, the femur shaft is also affected by the fracture.A pathologic fracture cannot be excluded.The fracture part of the shaft is healed; the subtrochanteric fracture shows a non-union.From a clinical point this is a typical nail fracture after 5 to 6 months caused by an intraoperative drill-damage of the nail and an overload in combination of a non-healing bone.The case is attributed to the patient contributed by the user.Non-unions, obesity, fractures with poor bone contact, postoperatively loads and intra-operatively implant damages are adverse effects that can lead to implant breakages and are listed in the ifu and operative technique.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
Event or Problem Description
It is reported by the surgeon of the hospital, that the g3 nail broke.Send request to sales rep to get further information.

• Brand Name: LONG NAIL KIT R2.0, TI, RIGHT GAMMA3® Ø11X340MM 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: 5846038
• Report Number: 0009610622-2016-00383
• Device Sequence Number: 19139323
• Product Code: HSB
• UDI-Device Identifier: 07613153312758
• UDI-Public: 0107613153312758111511021720103110K0DABE3
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2016

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: 10/31/2020
• Device Catalogue Number: 32250340S
• Device Lot Number: K0DABE3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/04/2016
• Supplement Report FDA Received Date: 11/16/2016
• 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