MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER GENERAL GLENOSPHERE GUIDE; SURGICAL INSTRUMENT FOR SHOULDER SURGERY

Catalog Number	04.01.10.0094
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 13 january 2020 lot 1850396: (b)(4) items manufactured and released on 17-apr-2018.No anomalies found related to the problem.To date, 2 other similar events have been reported.Three equal devices (same lot and reference number) have been reported in this complaint.Preliminary investigation performed by r&d shoulder manager: the provided pictures show that the terminal end of the "glenosphere guides" is scratched and outwardly deformed, which is likely the cause for the implant not to slide freely on the guide.Inspection of the damaged items is required to better understand the deformation of the hexagonal recess.Visual inspection performed by r&d shoulder manager: the instruments are confirmed to be damaged on both the outer surface and the hexagonal recess.Additional implant involved in the complaint, batch review performed on 13 january 2020 shoulder general 04.01.10.0094 glenosphere guide lot.1859419 lot 1859419: (b)(4) items manufactured and released on 02-jul-2019.No anomalies found related to the problem.To date, no other similar events have been reported.
Event or Problem Description
During the primary shoulder surgery, while putting on the glenosphere, it was observed that the glenosphere guides were damaged on the proximal end around the hex recess.One guide was damaged to the point that the screwdriver would not fit in.The second guide was not useable as it would push the glenosphere off the taper when trying to extract the guide.The agent had a second reverse tray available, and the guides in that tray seemed sufficient initially, but the surgery could not get the glenosphere to slide over the guide at all.It was observed that these guides were too bradded at the top and the last 2mm of the guide were too large for the glenosphere to fit over.The surgeon completed the case without the guides and used a retainment screw to help implant the glenosphere.There was a 3-hour delay in the case.Additional anesthesia had to be administered.The guides came from loaner sets.The surgery was completed successfully.

• Brand Name: SHOULDER GENERAL GLENOSPHERE GUIDE
• Common Device Name: SURGICAL INSTRUMENT FOR SHOULDER SURGERY
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 9675478
• Report Number: 3005180920-2020-00025
• Device Sequence Number: 11334898
• Product Code: LXH
• UDI-Device Identifier: 07630971210301
• UDI-Public: 07630971210301
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020

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 Catalogue Number: 04.01.10.0094
• Device Lot Number: 1850396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 02/06/2020
• 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: 65 YR