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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2019
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)).Visual inspection performed by r&d shoulder manager: the visual inspection confirmed that the nitinol wire detached from the main body due to the breakage of the cylindrical portion of the main body.The breakage may have been caused by excessive force applied on the wire during the glenosphere insertion (probably because of the tight shoulder condition).
Event or Problem Description
The glenosphere nitinol guide - body broke off during surgery.This was a large male patient with a very tight shoulder which made reducing the glenosphere on to the morse taper of the baseplate difficult, even with the assistance of the new guide wire.No metal fragment found on x-ray, the surgery was completed successfully.

• 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: 8412846
• Report Number: 3005180920-2019-00140
• Device Sequence Number: 11208925
• 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
• Report Date (Section B): 03/12/2019

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: 02/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/12/2019
• 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