MAUDE Adverse Event Report: TORNIER INC LATITUDE EV 5MM FLEXIBLE REAMER; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	9030394
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not returned.
Event or Problem Description
During a surgical procedure, the #5 flexible reamer broke while being used on a patient's elbow.Both pieces of the reamer were retrieved, and an x-ray was taken, which showed no abnormalities.The original intended procedure was the removal of hardware from the right elbow, insertion of a cement antibiotic spacer, irrigation and debridement of the right elbow, and bursectomy of the olecranon bursa.The user encountered problems related to device failure and malfunction.
Additional Manufacturer Narrative
Correction: b1 (adverse event/product problem), h5 (labeled for single use) , h8 (usage of device): the reported event was not 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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
During a surgical procedure, the #5 flexible reamer broke while being used on a patient's elbow.Both pieces of the reamer were retrieved, and an x-ray was taken, which showed no abnormalities.The original intended procedure was the removal of hardware from the right elbow, insertion of a cement antibiotic spacer, irrigation and debridement of the right elbow, and bursectomy of the olecranon bursa.The user encountered problems related to device failure and malfunction.

• Brand Name: LATITUDE EV 5MM FLEXIBLE REAMER
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: 18822873
• Report Number: 0001649390-2024-00080
• Device Sequence Number: 4500473
• Product Code: HWE
• UDI-Device Identifier: 00846832020089
• UDI-Public: 00846832020089
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2024

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: 9030394
• Device Lot Number: CV0520288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male