MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS GLENOID AND REVERSED PIN; SURGICAL ORTHOPEDIC INSTRUMENT

Model Number	DIAM.2.5 MM LENGTH 200MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the final report submitted regarding this surgical event and medical device.
Event or Problem Description
Tip of threaded pin snapped off inside patient's glenoid.No impact to patient.The tip was removed under x-ray.(additional surgical procedure required).

• Brand Name: AEQUALIS GLENOID AND REVERSED PIN
• Common Device Name: SURGICAL ORTHOPEDIC INSTRUMENT
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin, 38330 ; FR 38330
• MDR Report Key: 8207829
• Report Number: 3000931034-2019-00004
• Device Sequence Number: 13867287
• Product Code: HWE
• UDI-Device Identifier: 03700386931796
• UDI-Public: 03700386931796
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

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: No Information
• Device Expiration Date: 05/23/2023
• Device Model Number: DIAM.2.5 MM LENGTH 200MM
• Device Catalogue Number: DWD063
• Device Lot Number: 4281AT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/02/2019
• 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: 77 YR