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 Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch review performed on 24 july 2023 lot 1957912: (b)(4) items manufactured and released on 30-aug-2021.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review (2 items involved in this complaint).Additional instrument involved: batch review performed on 24 july 2023 on shoulder general 04.01.10.0421 flexible glenosphere guide lot.2256498 lot 2256498: (b)(4) items manufactured and released on 08-nov-2022.No anomalies found related to the problem.To date, no other similar events have been reported on the same lot during the period of review (2 items involved in this complaint, one lot is unknown).
Event or Problem Description
During the primary shoulder, when the surgeon was impacting the glenosphere, 2 flexible wires broke (near the base of the wire) and 2 glenosphere guides bent.The surgeon had to disimpact the head and had to abandon the post altogether and put the glenosphere on without a post.He was able to impact it onto the glenoid baseplate, but at an odd angle that engaged the morse taper partially.Therefore the post could not be pulled out.There was a 2-hour delay and the surgery was completed successfully.A loaner set was utilized and additional anesthesia was administered.
Additional Manufacturer Narrative
Visual inspection performed by medacta r&d shoulder manager: the two glenosphere guides are damaged on the outer surface.This led to the impossibility to slide the glenosphere on the guide.The items were manufactured in high nitrogen stainless steel as per drawing in force at that time.Project modification to modify has been done the material to reduce the occurrence rate of such issue.The flexible glenosphere guide is confirmed to be broken at the base of the wire.No action is suggested.

• 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, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 17448630
• Report Number: 3005180920-2023-00619
• Device Sequence Number: 12580179
• Product Code: LXH
• UDI-Device Identifier: 07630971210301
• UDI-Public: 07630971210301
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2023

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: 1957912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 07/17/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 91 KG