MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL 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	Not Applicable (3189)
Date of Event	06/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (52999), and no non-conformances were identified.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.Udi: (b)(4).
Event or Problem Description
It was reported by sales rep via complaint submission tool that during a rotator cuff repair, while using an expressew iii autocapture + retention plate/loading tool-5 pack, the retention plate would not load into device.No surgical delay or patient consequences reported.Additional information provided by the affiliate reported the procedure was successfully completed by opening a new retention plate.It was also reported there was a minor surgical delay of one minute which caused by retrieving a new device to use.The affiliate reported there were no known patient consequences.

• Brand Name: EXPRSEW III AC+ RTN PLATE 5PK
• Common Device Name: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10185155
• Report Number: 1221934-2020-01604
• Device Sequence Number: 3234000
• Product Code: LXH
• UDI-Device Identifier: 10886705027118
• UDI-Public: 10886705027118
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2020

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: 05/31/2024
• Device Model Number: 288234
• Device Catalogue Number: 288234
• Device Lot Number: 52999
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1