MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X280MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0280S
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/24/2017
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 on (b)(6) 2017 the breakage of a gamma3 nail r 2.0 11x280 / 125 degrees left was noticed.
Additional Manufacturer Narrative
The returned devices matched the report, and the complaint failure mode was confirmed.Referring to product inquiry the long nail kit r2.0, ti, left gamma3® ø11x280mm x 125° is stated to be the primary product and the locking screw lot code k0b8a74 as well.Remaining screws are considered to be concomitant items.Failures in material or manufacturing of the affected devices returned were not found.Dimensional examination revealed no deviations in the relevant undamaged areas of the nail and the locking screw returned.The affected items reported were documented as faultless prior to distribution.Thus, we exclude deviations in material and manufacturing.The received nail is completely broken in the webs of the proximal lag screw thru hole.One of both locking screws returned is completely broken approx.Midshaft.Mechanical damages at the nail ¿ drill marks at and inside the proximal drill hole and around the initial crack ¿ had been caused by contact with the step drill.Such damage causes additional notch effects.The appearance of the breakage surfaces, orientation of lines of rest and different topographies indicated the nail breakage had its origination in the anterior web where chamfer-like material abrasion was found at lateral.Significant material deformation (bearing points) of the medial edge of the proximal drill hole and in material deformation in the distal drill hole [round hole] was most likely caused by increased axial loading during the implantation period; which is considered as patient behaviour related.Regarding technical aspects in this case the nail and locking screw broke in fatigue manner after an implantation period of approx.24 days.During this period the implant had to absorb / transfer the whole loading because not relieved by increasing bone healing.Implant breakage may occur when the material is subjected to repeated loading and unloading resulting fatigue of material.If the loads are above a certain threshold (microscopic) cracks will begin to form on the surface.Intra-operative material damage at the lateral edge of the proximal drill hole most likely contributed to the origination of an incipient crack.Omitting pre-drilling for the placement of the k-wire may have contributed to deflection of the stepdrill (due to bone contour) during preparation for the canal for the lag screw.It could not be determined what range of weight bearing had been advised by the surgeon for the post-operative period.It could also not be determined if the patient had been compliant to the instructions.Evaluation revealed that the present breakage(s) of the nail and one of both locking screws was most likely caused by intra-operative material damage contributed by significant axial load application.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 are no actions in place related to the reported event for the subject product.According to available information a deficiency of the implants was not be verified.No non-conformity was identified.
Event or Problem Description
It was reported that on (b)(6) 2017 the breakage of a gamma3 nail r 2.0 11x280 / 125° left was noticed.Update on (b)(4) 2017 during a detailed visual inspection within physical evaluation it was noticed that one of both distal locking screws [lot code k0b8a74] was broken.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X280MM 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: 6583298
• Report Number: 0009610622-2017-00154
• Device Sequence Number: 18985910
• Product Code: HSB
• UDI-Device Identifier: 07613153313434
• UDI-Public: (01)07613153313434(11)160909(17)210831(10)K0CE3D9
• Combination Product (Y/N): N
• PMA/510(K) Number: K032898
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2017

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: 08/31/2021
• Device Model Number: 3325-0280S
• Device Catalogue Number: 33250280S
• Device Lot Number: K0CE309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Initial Date Received by Manufacturer: 04/26/2017
• Supplement Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 08/03/2017
• 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: 82 YR
• Patient Weight: 80