MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL DEPLOYMENT GUN; ORTHOPAEDIC CERCLAGE APPLIER

Model Number 228143

Device Problems Break (1069); Device-Device Incompatibility (2919)

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

Event Date 12/05/2021

Event Type  malfunction  

Event Description

It was reported by the customer in (b)(6) that during an anterior cruciate ligament reconstruction surgery on (b)(6) 2021, it was observed that the suture on the meniscal deployment gun device broke upon tightening and did not fire again after the first firing.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

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 n this report.If information is obtained that as not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device was received and evaluated.The needle with the second plate and the suture were returned.The silicone sleeve was found rolled up toward the tip of the needle, traces of biological matter were identified in the needle.The tip of the spring pusher is jammed between the plate and the needle causing a non deployment condition.The needle was removed and verified the spring pusher and the loading rod; no structural anomalies were found.A manufacturing record evaluation was performed for the finished device lot number: 6l40945, and no non-conformances were identified.According with the visual inspection result, this complaint can be confirmed.A possible root cause can be attributed to the damage on the silicone sleeve, this damage could have been caused by the surrounding instrumentation used in this procedure, the damaged silicone sleeve caused a mechanical blockage to the second plate when it was going to be deployed, however, this cannot be conclusively determined.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: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 13025950
• MDR Text Key: 287812786
• Report Number: 1221934-2021-03813
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• 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

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 6L40945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1