MAUDE Adverse Event Report: TORNIER INC TORNIER HUMERAL NAIL RIGHT DIA 8MMX130MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	0020500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices used: proximal screw x 3 distal screw x 1 based on the available information the device remains implanted in the patient therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Event or Problem Description
It was reported in a study that the patient had an increase in pain without injury.The patient was given 2ml kenalog, 2ml lidocaine, 7ml ropivacaine; injection into the shoulder articulation and subacromial space.A week later the patient was given1ml kenalog, 2ml lidocaine, 7ml ropivicaine, injected into the glenohumeral articulation.

• Brand Name: TORNIER HUMERAL NAIL RIGHT DIA 8MMX130MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18383180
• Report Number: 0001649390-2023-00367
• Device Sequence Number: 7712922
• Product Code: HSB
• UDI-Device Identifier: 00846832091065
• UDI-Public: 00846832091065
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K082754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 0020500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DISTAL SCREW: STATIC ONLY; PROXIMAL SCREW: GREATER TUBEROSITY HIGH; PROXIMAL SCREW: LESSER TUBEROSITY; PROXIMAL SCREW: MEDIAL CALCAR
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 73 KG