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

Model Number 228143

Device Problem Premature Activation (1484)

Patient Problem Not Applicable (3189)

Event Date 12/13/2019

Event Type  malfunction  

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.(b)(6).(b)(4).

Event Description

It was reported by affiliate via email, that during an unknown procedure, 2 anchors of meniscal applier, omnispan were fired at the same time (during the first firing).Material had to be removed from the patient and a new omnispan had to be used to complete the procedure.There was a delay of about 5 minutes.No patient consequence reported.Additional information provided by the affiliate reported the device will not be returning for evaluation because it was discarded by the customer.

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: additional information: h6; method codes: device history lot
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> a manufacturing record evaluation was performed for the finished device [6l19178] number, and no non-conformances were identified 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.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [6l19178] number, and no non-conformances were identified since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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
• MDR Report Key: 9526688
• MDR Text Key: 192144071
• Report Number: 1221934-2019-60182
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 228143
• Device Catalogue Number: 228143
• Device Lot Number: 6L19178
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1