MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	33250360S
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/11/2018
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 was reported that nail was implanted on (b)(6) 2018 because of a subtrochanteric femur fracture.Patient came in with broken nail.Follow-up was without any problems, however on (b)(6) 2018 the patient came in with a broken nail (right leg).
Additional Manufacturer Narrative
The reported event of implant breakage was confirmed.According to available information a long gamma3 nail had broken after an implantation period of approx.3 months.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.General aspects: loads on the device produced by load bearing and the patient's activity level will dictate the longevity of the device.Conditions attributable to non-union, osteoporosis, osteomalacia, diabetes, inhibited revascularization and poor bone formation can cause loosening, bending, cracking, fracture of the device or premature loss of rigid fixation with the bone.One requirement for successful nail treatment is a timely bone healing in order to relieve the nail over the progressing time of implantation.Potential adverse effects, e.G.Overweight, increased loading or material damage are clearly pointed out in the labelling.In this case the nail had broken in a fatigue manner.The incipient crack was found at lateral in the anterior web where intra-operative material damage had weakened the material and had caused a notch effect.Deformed edges in the bearing points at medial / inferior indicate high load application during the implantation period.As no instructions regarding post-operative weight bearing were available it could not be determined if the patient had been compliant to the surgeon¿s instructions.A medical assessment was not possible due to undated x-rays of poor quality.However, the consulted surgeon was not concerned about a revision of this kind in an overweight patient lasting around 250 minutes.From technical point of view the nail had broken in a fatigue fracture caused by intra-operative damage; most likely contributed by high load application (patient¿s weight and activity).Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated nail breakage was addressed adequately.There were no actions in place related to the reported event for the subject product.No non-conformity was identified.With available information a deficiency of the device was not verified.Intra-operative material damage was regarded as user related.In case the relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.
Event or Problem Description
It was reported that nail was implanted on (b)(6) 2018 because of a subtrochanteric femur fracture.Patient came in with broken nail.Follow-up was without any problems, however on (b)(6) 2018 the patient came in with a broken nail (right leg).

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X360MM 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: 7656885
• Report Number: 0009610622-2018-00267
• Device Sequence Number: 2012004
• Product Code: HSB
• UDI-Device Identifier: 07613153313519
• UDI-Public: 07613153313519
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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: 10/31/2022
• Device Catalogue Number: 33250360S
• Device Lot Number: K0A49BF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 11/15/2018
• 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: 77 YR