MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL EXPRESSEW III AC+ GUN; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 288233

Device Problems Use of Device Problem (1670); Difficult to Advance (2920)

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

Event Date 10/20/2023

Event Type  malfunction  

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.H10 additional narrative: e3: reporter is a j&j affiliate.H4: the device manufacture date is currently unavailable.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.

Event Description

This is report 2 of 2 for (b)(4).It was reported by the affiliate in japan that during an arthroscopic rotator cuff repair for a rotator cuff tear surgery on (b)(6) 2023, it was observed that while using the expressew iii autocapture+ loading tool/retention plate and expressew iii autocapture+ flexible suture passer, the upper jaw at the tip of the autocapture got slightly damaged, resulting in poor engagement, making it difficult for the needle to penetrate the rotator cuff.While moving the autocapture in various directions under the acromion, the retention plate dislodged into the deltoid muscle.The surgeon slightly widened the incision and removed the dislodged retention plate.After that, the surgeon loaded a new retention plate on the autocapture and continued the procedures.The surgery was completed successfully.There was no harm to the patient and no surgical delay.The device was brand new and the first use when the issue occurred.No additional information was provided.

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.Investigation summary the complaint device is not being returned, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If additional information or the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a 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 with which this complaint is observed in the field.

• Brand Name: EXPRESSEW III AC+ GUN
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18038054
• MDR Text Key: 326949779
• Report Number: 1221934-2023-03933
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 10886705027101
• UDI-Public: 10886705027101
• Combination Product (y/n): N
• 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,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 288233
• Device Lot Number: F000040709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2023
• 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