MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0400S
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information is available at this time due to the ongoing litigation.Should additional information become available, the evaluation summary will be submitted in a supplemental report.Device disposition is unknown.
Event or Problem Description
Lawyer of patient reports that on (b)(6) 2016 patient had surgery due to femural neck fracture.The reported nail was implanted.Thereafter, the patient did not hurt himself, did not fall, etc, yet felt pain and returned to the hospital.On (b)(6) 2016 it was discovered that the nail was broken.
Event or Problem Description
Lawyer of patient reports that on (b)(6) 2016 patient had surgery due to femoral neck fracture.The reported nail was implanted.Thereafter, the patient did not hurt himself, did not fall, etc, yet felt pain and returned to the hospital.On (b)(6) 2016 it was discovered that the nail was broken.
Additional Manufacturer Narrative
Evaluation revealed the broken nail and the broken locking screw to be primary products whereof the broken nail was regarded as main product.For both units no deviations were found during review of the manufacturing and inspection documents (dhr).Both implants were documented as faultless prior to distribution.No deficiency found during dimensional inspection of the returned product.Available information revealed that the nail allegedly broke after a period of approx.2 months of implantation.The appearance of the breakages surfaces indicated the nail had broken in fatigue manner contributed by significant tensile and torsion stresses.In this case, according to x-rays dated (b)(6) 2016, the locking screw had broken prior to the nail.Nail breakage was clearly documented on (b)(6) 2016.Medical review revealed the implants had been placed in a complex oblique four part fracture.Full weight bearing on the left leg had been allowed.From technical point of view the returned nail broke in fatigue manner contributed by high load application confirmed by significant displaced material in the medial bearing points.It could not be determined if the missing proximal part of the nail had been damaged intra operatively.From technical point of view the not returned screw most likely broke due to exceeding axial load application.As no deviation was found in the manufacturing documents a deficiency of the documented nail and screw was not verified.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 the issue was addressed adequately.There were no actions in place related to the reported event for the subject product.No nonconformity was identified.Potential adverse events and potential root causes are / were stated in the labeling.The event was not linked to a deficiency of the devices but was rather linked to patient factors.In case further information is received the investigation reopened.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X400MM 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: 6919497
• Report Number: 0009610622-2017-00315
• Device Sequence Number: 890686
• Product Code: HSB
• UDI-Device Identifier: 07613153313564
• UDI-Public: (01)07613153313564(11)151120(17)201031(10)K03668C
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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: 10/31/2020
• Device Model Number: 3325-0400S
• Device Catalogue Number: 33250400S
• Device Lot Number: K03668C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Initial Date Received by Manufacturer: 09/13/2017
• Supplement Date Received by Manufacturer: 02/08/2018
• Initial Report FDA Received Date: 10/06/2017
• Supplement Report FDA Received Date: 03/07/2018
• 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