MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA SHOULDER SPECIFIC MADE GLENOSPHERE NITINOL GUIDE; SURGICAL INSTRUMENT FOR SHOULDER

Catalog Number	04.01.10.0421
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 12 march 2019: lot 1858331: (b)(4) items manufactured and released on 28-jan-2019.No anomalies found related to the problem.To date, another similar event has been reported on this lot (complaint (b)(4) [mdr 2019-00140]).Preliminary investigation performed by r&d shoulder manager: the wire appears to be detached due to the breakage of the crimped portion of the main body.This may have been caused by excessive force needed to align the glenosphere on the guide (probably because of the tight shoulder condition).
Event or Problem Description
During the primary shoulder surgery and upon inserting the glenosphere, the glenosphere guide with nitinol broke and a fragment remained into the glenosphere.The surgeon removed the glenosphere, removed the broken fragment from the glenosphere and used general instrumentation to re-insert the glenosphere.There was a 10 minutes delay in the case and the surgery was completed successfully.
Additional Manufacturer Narrative
Visual inspection performed by r&d shoulder manager: the visual inspection confirmed that the main body of the "glenosphere nitinol guide" broke in the region of crimpage of the wire.The wire presents a bent at the level of conjunction with the main body, likely for high force applied during the insertion of the glenosphere.

• Brand Name: SHOULDER SPECIFIC MADE GLENOSPHERE NITINOL GUIDE
• Common Device Name: SURGICAL INSTRUMENT FOR SHOULDER
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8421116
• Report Number: 3005180920-2019-00159
• Device Sequence Number: 13500874
• Product Code: LXH
• UDI-Device Identifier: 07630971238176
• UDI-Public: 07630971238176
• 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,Followup
• Report Date (Section B): 04/17/2019

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: 04.01.10.0421
• Device Lot Number: 1858331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Supplement Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/17/2019
• 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