MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED BIO-RSA REAMER

Model Number	REAMER 3 IN 1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medwatch submitted: (b)(4).
Event or Problem Description
The tornier bio rsa reamer, which is used to harvest a bone graft from the humeral head, broke into two pieces while the graft was being harvested.
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.The information contained in this report is being provided to the fda to comply with regulations regarding medical device reporting and is based on information submitted by others that may or may not be factually correct.This submission does not constitute a determination or admission that a device has malfunction or is related to a death or injury.

• Brand Name: AEQUALIS REVERSED BIO-RSA REAMER
• Common Device Name: AEQUALIS REVERSED BIO-RSA REAMER
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 9897201
• Report Number: 3000931034-2020-00050
• Device Sequence Number: 701136
• Product Code: HWE
• UDI-Device Identifier: 03700386977596
• UDI-Public: 03700386977596
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Model Number: REAMER 3 IN 1
• Device Catalogue Number: MWF702
• Device Lot Number: 16C023
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR