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

Model Number 228143

Device Problems Misfire (2532); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (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.(b)(6).(b)(4).

Event Description

It was reported by affiliate via phone that during the surgery of meniscus repair, after 1st firing with 228143(meniscal deployment gun) and 228141(omnispan meniscal repair 12deg), two plates were deployed at the same time.Changed another 228141, the event re-happened.Changed another 228141,could not fire, suspect the inner spring was stuck which result the gun could not fire.Another gun and needle were used to complete the surgery.There were no adverse consequences to the patient.No additional information could be provided.The devices are not available to be returned for evaluation.

Manufacturer Narrative

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.H10 additional narrative: investigation summary
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> the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.The inner spring being stuck is a possible root cause of the reported problem.However without the return of the complaint device, and no further information provided we cannot determine a definitive root cause.A manufacturing record evaluation was performed for the finished device lot number (5l45448), 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device lot number (5l45448), and no non-conformances were identified.

• Brand Name: MENISCAL DEPLOYMENT GUN
• Type of Device: ORTHOPAEDIC CERCLAGE APPLIER
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10010309
• MDR Text Key: 207965539
• Report Number: 1221934-2020-01264
• Device Sequence Number: 1
• Product Code: GEF
• UDI-Device Identifier: 10886705010059
• UDI-Public: 10886705010059
• 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,health professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 5L45448
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Patient Sequence Number: 1