MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3325-0380S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	01/23/2020
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 reports a breakage of the nail.A revision surgery was performed.
Additional Manufacturer Narrative
The reported event could be confirmed, since the device was returned for evaluation and matches the reported failure mode.The received device inspection revealed the following: the nail was completely broken in the thinned webs of the proximal drill hole for the lag screw.Drill marks are found at the inside of the posterior web running from lateral towards medial.Significant material abrasion was found in the anterior web at lateral.Deep scratches and additionally material deformed outside were most likely caused by a deviating of the step drill during preparation of the canal for the lag screw, material damage had led to sharp edges in the breakage line resulting in significant material weakening.The appearance of the breakage surfaces suggested the nail had broken in fatigue manner ¿ indicated by the lines of rest, smooth surface and missing plastic deformation.The incipient crack had started at the smallest cross section at lateral and had progressed towards medial.Typical bearing points in the proximal drill hole were identified at lateral / superior and at medial / inferior.A significant bearing point was also found in the round drill hole at distal.Based on the provided medical records, the medical opinion was sought from experienced independent medical expert which revealed the following; ¿due to non-union first the screws broke as a result of ¿self-mobilization¿ and compression, when the non-union prolonged, the nail broke.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the investigation the root cause of the failure is a combination of both user and patient related issue.However, predominantly the root cause would be user related as significant material damage had weekend the web caused by misaligned drilling with the step drill and further due to nonunion increased axial loading during the implantation period nail was broken.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The customer reports a breakage of the nail.A revision surgery was performed.

• Brand Name: LONG NAIL KIT R2.0, TI, LEFT GAMMA3® Ø11X380MM 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; DE D-24232
• MDR Report Key: 9721514
• Report Number: 0009610622-2020-00057
• Device Sequence Number: 16225631
• Product Code: HSB
• UDI-Device Identifier: 07613153313533
• UDI-Public: 07613153313533
• Combination Product (Y/N): N
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 09/30/2023
• Device Model Number: 3325-0380S
• Device Catalogue Number: 33250380S
• Device Lot Number: K0461BF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 05/12/2020
• 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: 67 YR