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	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 06 may 2019: lot 1858331: (b)(4) items manufactured and released on 28-jan-2019.No anomalies found related to the problem.To date, three other similar events have been reported on this lot (complaint (b)(4)).
Event or Problem Description
During the surgery the glenosphere nitinol guide broke at wire-instrument metal shaft connection level.The surgery was completed successfully and without delay using the standard guide.
Additional Manufacturer Narrative
It was declared that the device was not available.However it was received on 2nd of december 2019.Visual inspection performed on december 4th 2019 by r&d shoulder manager: the visual inspection performed confirmed that the flexible wire is broken at the conjunction with the main body of the instrument.No sign of damage or deformation is visible on the collar of the main body, where the flexible wire is attached to.The breakage may have been caused by excessive force applied on the wire during the glenosphere insertion.

• 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, 6874 ; SZ 6874
• MDR Report Key: 8591160
• Report Number: 3005180920-2019-00363
• Device Sequence Number: 2293880
• Product Code: LXH
• UDI-Device Identifier: 07630971238176
• UDI-Public: 07630971238176
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/11/2019

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: 12/02/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/08/2019
• Supplement Report FDA Received Date: 12/11/2019
• 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: 82 YR
• Patient Weight: 60