MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL EXPRSEW III AC+ RTN PLATE 5PK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	288234
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by sales rep that during a rotator cuff repair procedure, it was observed that the expressew iii autocapture + retention plate/loading tool-5 pack had a defective plate.During in-house engineering evaluation, it was determined that the plate was already out of the loading tool.There was an unspecified delay in the procedure while looking for the first plate to make sure it was not in the patient.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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 depuy mitek or its employees that the report constitutes an admission that the device, depuy 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.H10 additional narrative: udi: (b)(4).H4: the device manufacture date is currently unavailable.Investigation summary: both photo of the device and the actual device were received for evaluation.Photos were provided for review, however the photos only show the product label which contains the part and lot number and no other observation pertaining to the nature of the reported event could be identified.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Therefore, the overall complaint could not be confirmed as the photographs provided contained insufficient evidence of the reported event.Visual inspection of the actual device found that the device is in used condition.The plate was already out of the loading tool.The loading tool is in good condition as well as the plate.No structural anomalies were found.The overall complaint was confirmed as the observed condition of the exprsew iii ac+ rtn plate 5pk would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; loading incorrectly which causes the plate to detach and/or deform.As per ifu; while maintaining the loading tool in a flat position (do not angle or rotate), slide the loading tool forward until it stops.Slide the loading tool off the instrument and discard.Visually inspect the top jaw of the flexible suture passer to ensure that the retention plate was fully assembled.Plate tabs should be in pocket of top jaw.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 depuy synthes 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.

• Brand Name: EXPRSEW III AC+ RTN PLATE 5PK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; 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: 19041929
• Report Number: 1221934-2024-01094
• Device Sequence Number: 8483008
• Product Code: LXH
• UDI-Device Identifier: 10886705027118
• UDI-Public: 10886705027118
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 288234
• Device Lot Number: 69741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 04/04/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown