MAUDE Adverse Event Report: TORNIER INC AEQUALIS HUMERAL NAIL TARGETING JIG; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	AHN0337
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
The sighting nail guide is broken, as is a locking lever.A piece is still in the patient.
Event or Problem Description
The sighting nail guide is broken, as is a locking lever.A piece is still in the patient.
Additional Manufacturer Narrative
Correction: h6 component code.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 visual inspection of the returned product reveals signs of breakage and wear.The tip of the jig sleeve where the nail connects the targeting jig is broken.The locking screw on one side does not hold the side lock, therefore the side lock is loose.The edges where the side lock is present is worn out and has rust/corrosion spots.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 investigation, the root cause was attributed to a combination of user and wear related issue.The failure was caused by application of impactful external forces combined with the frequent usage involving multiple sterilization cycles since may 2018.Additionally, the fact that the device was manufactured back in 2016 and is in use from may 2018, it is safe to say that it has performed the former surgeries as intended without any reported abnormalities.If any further information is provided, the complaint report will be updated.

• Brand Name: AEQUALIS HUMERAL NAIL TARGETING JIG
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17578406
• Report Number: 0001649390-2023-00200
• Device Sequence Number: 19733004
• Product Code: FZX
• UDI-Device Identifier: 00846832068067
• UDI-Public: 00846832068067
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AHN0337
• Device Lot Number: DB0116207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 10/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown