MAUDE Adverse Event Report: STRYKER GMBH LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 120°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	3420-0320S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Failure of Implant (1924); Limb Fracture (4518)
Date of Event	06/21/2023
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 postoperatively the nail broke off at the lag screw hole due to a fall, leading to a re-fracture and revision surgery.
Event or Problem Description
It was reported that postoperatively the nail broke off at the lag screw hole due to a fall, leading to a re-fracture and revision surgery.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not 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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: LONG NAIL KIT R1.5, TI, RIGHT GAMMA3® Ø10X320MM X 120°
• 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: 17347352
• Report Number: 0009610622-2023-00261
• Device Sequence Number: 20350804
• Product Code: HSB
• UDI-Device Identifier: 04546540375209
• UDI-Public: 04546540375209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2023

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: 09/30/2026
• Device Model Number: 3420-0320S
• Device Catalogue Number: 34200320S
• Device Lot Number: K03085F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• 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: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian