MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA MECTALOCK IMPLANTS 05.10.002 MECTALOCK PEEK Ø2.9 - SHORT DRIVER; MECTALOCK IMPLANTS SHORT DRIVER

Catalog Number	05.10.002
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
During the sports-med shoulder arthroscopy and while inserting an anchor into the patient's bone, the tip of the mectalock peek ø2.9 - short driver broke off at the thread/hub interface and was unable to be retrieved from the implanted anchor.The surgery was anyway completed successfully.
Additional Manufacturer Narrative
Batch review performed on 06-dec-2023.Lot 2227483: (b)(4) items manufactured and released on 06-feb-2023.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Analysis performed by r&d manager: the breakage of the inserter occurred in correspondence to the change of section between the distal cylindrical portion and the thread, leaving the most distal pin (thread + cone) within the peek anchor.The breakage in this section suggests that the assembled inserter and anchor have been subjected to considerable lateral loads.A possible cause could be that the direction of impaction of the anchor was not potentially fully aligned with the pilot hole axis, previously drilled.Specially in case of very hard bone, hitting the anchor against a solid wall o the pilot hole's rim could generate excessive side loads on the anchor and the inserter itself.Hammering the inserter in this configuration may result in an unforeseeable lateral hitting load condition, bringing to the weakest section breakage.The constrained condition of the pilot hole prevented the anchor from failing (internally also supported by the metal pin) concentrating the loads on the interface section between the anchor and inserter.

• Brand Name: MECTALOCK IMPLANTS 05.10.002 MECTALOCK PEEK Ø2.9 - SHORT DRIVER
• Common Device Name: MECTALOCK IMPLANTS SHORT DRIVER
• 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: 18382651
• Report Number: 3005180920-2023-01022
• Device Sequence Number: 18092072
• Product Code: MBI
• UDI-Device Identifier: 07630040727761
• UDI-Public: 07630040727761
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K190474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 05.10.002
• Device Lot Number: 2227483
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2023
• 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 Sex: Male