MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRSEW III AC+ RTN PLATE 5PK; SUTURE/NEEDLE PASSER, SINGLE-USE

Model Number	288234
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi:(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a rotator cuff repair procedure on (b)(6) 2021, it was observed that the retention plate on the exprsew iii ac+ rtn plate did not connect with the top jaw that the plate was found inside the insertion chamber.Another like device was used to complete the procedure with a delay of one minute.There were no adverse patient consequences reported.No additional information was provided.
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.H4: the device manufacture date was unknown in the initial report and has been updated 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 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.Investigation summary: according to the information provided, it was reported that the expressew ac plate did not connect to the top jaw.Plate was found inside the insertion chamber.The complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation, however the customer provided a photo of the product label which contains the product code and the lot number, these numbers were verified, and they are correct.A manufacturing record evaluation was performed for the finished device 58338 number, and no non conformances were identified.As part of depuy synthese mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection of the photo, this complaint cannot be confirmed.The photo provided does not contain enough evidence to determine why the customer experienced the failure, hands on analysis should provide the evidence necessary to provide a root cause.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: EXPRSEW III AC+ RTN PLATE 5PK
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 12159168
• Report Number: 1221934-2021-02183
• Device Sequence Number: 4660104
• Product Code: LXH
• UDI-Device Identifier: 10886705027118
• UDI-Public: 10886705027118
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2021

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 Expiration Date: 07/31/2025
• Device Model Number: 288234
• Device Catalogue Number: 288234
• Device Lot Number: 58338
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Supplement Date Received by Manufacturer: 07/19/2021; 08/03/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 07/20/2021; 08/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1