MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL, LEFT GAMMA4 Ø13X440MM X 130°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85303440S
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	04/23/2024
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 during a post op follow up visit a consultant discovered broken gamma4 nail.Patient required a hip arthroplasty due to nail failure and fracture non-union.Gamma4 nail snapped at proximal end at lag screw hole.
Additional Manufacturer Narrative
The reported event could be confirmed, since the nail was returned broken.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.Visual inspection the nail was completely broken in the thinned webs of the proximal drill hole for the lag screw.The appearance of the breakage surfaces identified the nail had broken in fatigue manner ¿ indicated by lines of rest and missing plastic deformation.The incipient crack had started at the smallest cross section at lateral in the anterior web and had progressed towards medial.In this area damages like drill marks and seized material were found.Drill marks were caused intra-operatively by contact with the step drill while preparing the cannulation for the lag screw.Removed material had weakened the material.Seizing was caused by contact with the lag screw including increased motion due to the progress of the crack.Overlying stresses had contributed to the origin of the incipient crack in the anterior web.From technical point of view, the breakage was caused by intra- and post operative damage.The bone had fractured in the sub trochanteric area exceeding with a spiraled fracture towards distal.From medical point of view, the nail broke at an earlier stage, because the construct was just not strong enough for this complex fracture type.There was no stability given because the large middle fragment, so the weight of the patient is completely on the lag screw / nail interface.Based on investigation, the root cause was attributed to a user related issue potentially contributed by the patient¿s mobility.With available information a product deficiency was not verified.
Event or Problem Description
It was reported that during a post op follow up visit a consultant discovered broken gamma4 nail.Patient required a hip arthroplasty due to nail failure and fracture non-union.Gamma4 nail snapped at proximal end at lag screw hole.

• Brand Name: LONG NAIL, LEFT GAMMA4 Ø13X440MM X 130°
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• 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: 19281854
• Report Number: 0009610622-2024-00189
• Device Sequence Number: 6358496
• Product Code: HSB
• UDI-Device Identifier: 07613327473742
• UDI-Public: 07613327473742
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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 Catalogue Number: 85303440S
• Device Lot Number: K13AF49
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2023
• 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