MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL CORACOID OFFSET PIN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	288206
Medical Device Problem Codes	Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device was used for treatment, not diagnosis.H11 additional narrative: e3: reporter is a j&j sales representative.H4: the device manufacture date is currently unavailable.Investigation summary: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found that the device comes in used condition as expected in reusable devices.The offset pin was found bent at the distal tip.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was not confirmed as the observed condition of the coracoid offset pin would have not contributed to the complained device issue.Based on the investigation findings, the potential cause for the bent offset pin is traced to hard and continuous use; since this is a reusable device, the constant manipulation between surgeries and sterilization process can lead to bent offset pin, however, this cannot be conclusively determined.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.
Event or Problem Description
It was reported from australia that two sets of devices had blunt instruments.It was reported that the two coracoid top hat drill devices, two sharp curved osteotome devices, a combo screwdriver, and a coracoid offset pin were blunt.It was not reported if the event occurred during a surgical procedure.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.This is report 6 of 6 for the same event in (b)(4).

• Brand Name: CORACOID OFFSET PIN
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 21217797
• Report Number: 1221934-2025-00303
• Device Sequence Number: 18339430
• Product Code: LXH
• UDI-Device Identifier: 10886705026845
• UDI-Public: (01)10886705026845(10)16E06
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 288206
• Device Lot Number: 16E06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown