MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X420MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	34301420S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); No Code Available (3191)
Date of Event	11/27/2018
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
The customer reported that the patient who had been implanted with a gamma nail was revised following a fall.Revision surgery on (b)(6), completed successfully using a non-stryker device.
Event or Problem Description
The customer reported that the patient who had been implanted with a gamma nail was revised following a fall.Revision surgery on (b)(6), completed successfully using a non-stryker device.
Additional Manufacturer Narrative
The reported event that long nail kit r1.5, ti, right gamma3® 11x420mm x 130° was alleged of 'revision' could be confirmed.Based on investigation, the root cause was attributed to be patient related.The failure was caused by the fall of the patient, as reported in the event description.The device inspection revealed the following: the device was returned and was indeed broken in two parts at the level of the lag screw hole.Significant material abrasion was found in the medial side of the screw hole, as well as at the top of the screw hole.Material had been damaged by drill marks up to the superior edge ¿ most likely caused by a deviating of the step drill during preparation of the canal for the lag screw.Material damage may lead to sharp edges in the breakage line resulting in significant material weakening.The appearance of the breakage surfaces suggested the nail had broken in a sudden manner following a high energy ¿ indicated by the appearance of the breakage surface where both surfaces are not shiny and where the grain of the material is dark gray.Furthermore, it can be noticed that the inferior medial side of the lag screw hole sees extensive deformation, most likely due to traction compression forces applied to the material at this level by the lag screw at each step on the patient.The fracture pattern also suggests a breakage in torsion.Further remarkable damages were not determined.The breakage surface description a aforementioned is a proof that the device broke following a high energy event, such as a fall, which is exactly what is reported in the event description.The implants are not supposed to withstand such shocks.As a reminder, it is clearly stated in the ifu that: post-operative patient activity: these implants are neither intended to carry the full load of the patient acutely, nor intended to carry a significant portion of the load for extended periods of time.For this reason postoperative instructions and warnings to patients are extremely important.External immobilization (e.G.Bracing or casting) may be employed until x-rays or other procedures confirm adequate bone consolidation.The surgeon must warn the patient that the device cannot and does not replicate a normal healthy bone, that the device can break or become damaged as a result of strenuous activity, trauma, mal union or nonunion and that the device has a finite expected service life and may need to be removed at some time in the future.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.If any further information is provided, the investigation report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø11X420MM X 130°
• 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: 8182750
• Report Number: 0009610622-2018-01517
• Device Sequence Number: 16505645
• Product Code: HSB
• UDI-Device Identifier: 07613252274001
• UDI-Public: 07613252274001
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2019

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 34301420S
• Device Lot Number: K084ECE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 02/13/2019
• 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