MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR, 0DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	228140
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	06/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by distributor via email that during an anterior cruciate ligament reconstruction + meniscus suture, three meniscal applier, omnispan, did not fire the needle, two omnispan meniscal repair system/0 degree were opened and fired, but then stopped.Then they opened a omnispan meniscal repair system/12 degree which fired three needles but they did not hold.Shots were made with the applicator but the needles did not hold to the meniscus.The surgery was converted to open to solve problem.No surgical delay or patient consequences reported.Devices were discarded.
Additional 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.H10 additional narrative: 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.A manufacturing record evaluation was performed for the finished device lot number (l946765), 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.
Additional 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.Additional narrative: additional information: subsequent follow-up with the customer, additional information was received.Will the patient¿s hospital/rehab stay be prolonged beyond what was anticipated? was the hospital stay prolonged? there was no need.Did the patient receive intra-op/post op medications beyond the standard antibiotics/steroids/pain medications due to converting to open procedure? not applicable.Any medical complications due to this conversion ¿ unanticipated infection, prolonged anesthesia causing patient distress? not applicable.

• Brand Name: OMNISPAN MENISCAL REPAIR, 0DEG
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10225200
• Report Number: 1221934-2020-01745
• Device Sequence Number: 548345
• Product Code: MAI
• UDI-Device Identifier: 10886705010028
• UDI-Public: 10886705010028
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 228140
• Device Catalogue Number: 228140
• Device Lot Number: L946765
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/07/2020; 07/27/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 07/08/2020; 07/27/2020
• Patient Sequence Number: 1