MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL EXPRESSEW III AC+ GUN; SUTURE/NEEDLE PASSER, REUSABLE

Model Number 288233

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Udi: (b)(4) incomplete.The lot was unknown.The lot number was unknown; therefore, the expiration date, manufacturing site name, and device manufacture date were unknown.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.Given that the lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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 to which this complaint is observed in the field.

Event Description

It was reported by the affiliate in (b)(6) that during an arthroscopic rotator cuff repair surgery on an unknown date, it was observed when the passer while loaded with a retention plate was in use, the needle did not return to its original position on the expressew iii ac+ gun device.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.The device was brand new and the first use when the issue occurred.

• Brand Name: EXPRESSEW III AC+ GUN
• Type of Device: SUTURE/NEEDLE PASSER, REUSABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle CH-24-00 ; SZ CH-2400 ; 6013142063
• MDR Report Key: 13344918
• MDR Text Key: 290533118
• Report Number: 1221934-2022-00286
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• 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
• Device Operator: Health Professional
• Device Model Number: 288233
• Device Catalogue Number: 288233
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1