MAUDE Adverse Event Report: STRYKER GMBH G4 LONG NAIL LEFT D10XL380MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250380S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/15/2023
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 a revision surgery on a gamma 4 nail on was performed a few months after the initial surgery.The nail broke right at the lag screw interface.
Event or Problem Description
It was reported that a revision surgery on a gamma 4 nail on was performed a few months after the initial surgery.The nail broke right at the lag screw interface.
Additional Manufacturer Narrative
The reported event could be confirmed, since the broken nail was returned for investigation.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.The device inspection revealed the following: 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 the edge was damaged by drill marks.This was caused intra-operatively by contact with the step drill while preparing the cannulation for the lag screw.Removed material had weakened the material significantly.Additionally, a 2nd material damage was found below above drill mark.Manufacturing and inspection records confirmed the item had been released in accordance to specs.Although the nail was broken a pin gauge ohl did not pass the proximal drill hole.Dimensional inspection on the returned item revealed no safe values due to deformations caused by the breakage.The raw material certificate confirmed the material to be the same as defined on the drawing and to the internal material specification.Above data had additionally been confirmed by mandatory examination prior to manufacturing.1 undated x-ray copy in a-p-view was provided showing the broken nail and the bone breakage.No other medical information was provided.With only 1 medical document, in one plane, a thorough medical review was not possible.If more information is provided, we reserve the right to re-open the case and to re-assign the root cause.Based on investigation, the root cause was attributed to a user related issue.With available information a deficiency of the implant was not verified.

• Brand Name: G4 LONG NAIL LEFT D10XL380MM X 125DEG
• 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: 17712463
• Report Number: 0009610622-2023-00303
• Device Sequence Number: 17821813
• Product Code: HSB
• UDI-Device Identifier: 07613327477627
• UDI-Public: 07613327477627
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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 Catalogue Number: 85250380S
• Device Lot Number: K0C4023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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: 89 YR
• Patient Sex: Unknown