MAUDE Adverse Event Report: STRYKER TRAUMA KIEL LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X360MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3425-0380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	11/25/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a gamma nail broke approx.3 months post surgery, resulting in a revision surgery.
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 a gamma nail broke approx.3 months post surgery, resulting in a revision surgery.
Additional Manufacturer Narrative
Please note the corrections to d1, d4 catalog # and gtin.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received nail is completely broken in the webs of the proximal lag screw hole.Significant drill marks, with chamfer-like material removal, were observed on the lateral side of the proximal segment of the broken nail and progressing toward the medial side.The drill marks were generated by a deviated lag screw step drill which most likely had created the starting point of the fracture (notching effect) at the lateral edge.The mis-drilling had also extended downwards along the anterior web.At the lag screw bearing point on the medial side of the distal part shows heavy deformation.A similar feature is visible on the lateral side of the proximal segment.This deformation indicates that the nail was exposed to high loads over a longer period of time.The fracture pattern resembles a fatigue break of the nail, evident by the appearance of lines of rest running from lateral to medial.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.X-rays were provided which were presented to our health care professional for evaluation, and a question about the most likely reason for the breakage was asked, to which the medical expert replied: ¿it is likely to be a non-union.Even though there is only one x-ray available, it looks like nothing much happened during the healing process up to nov 1st.As is known from similar cases that were judged by us, this is similar.The reverse trochanteric fracture is a difficult fracture.If there is not enough stability and or patient biology (or both) continuous movement may cause a bone healing problem.¿ based on the above investigation and available information, the root cause of the failure is deemed to be both user and patient-related.The appearance of mis-drilling marks indicates that the nail was damaged intra-operatively which may have led to the weakening of the nail initially.Further to this complex nature of the fracture, non-union and the simultaneous overloading on the whole construct ultimately led to the breakage of the nail in a fatigue manner.As a secondary finding, it was observed that the nail used in the surgery had expired before the surgery, as indicated in the product label.If any further information is provided, the complaint report will be updated.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X360MM 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; GM D-24232
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16014667
• Report Number: 0009610622-2022-00596
• Device Sequence Number: 6604767
• Product Code: HSB
• UDI-Device Identifier: 04546540375353
• UDI-Public: 04546540375353
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 09/30/2020
• Device Model Number: 3425-0380S
• Device Catalogue Number: 34250360S
• Device Lot Number: K0C2304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male