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

Model Number	0020500
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Limb Fracture (4518); Implant Pain (4561)
Date of Event	05/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was complaining of pain and tearing noises in arm.X-rays showed avn (avascular necrosis) with medial humeral head collapse.The patient will get a metal suppression mri and lab work to determine if there is a low grade infection.The event is ongoing.
Additional Manufacturer Narrative
Based on the available information the device will not be returned 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.

• 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: 14738636
• Report Number: 0001649390-2022-00024
• Device Sequence Number: 5936304
• 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
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2022

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 Model Number: 0020500
• 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: 05/23/2022
• Initial Report FDA Received Date: 06/17/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Unknown
• Patient Weight: 64 KG