MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 12DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228141

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 the affiliate via phone that during a meniscus repair after 1st firing of the omnispan meniscal repair 12deg the plate couldn¿t hold the tissue and pulled out with the needle.Another device was used and the same issue occurred.No patient consequence and no surgical delay was reported.No additional information was provided.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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: d10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not quen d reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes,eor its emsloye s ct she dr ice, depuy synthes, or its employees caud in this report.D evicr wasonsed oor treatment< not diagnailable for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary =the gun was not received along with the needle.Upon visual inspection, one of the implant was in released condition but attached to the suture at the distal end of the silicon sleeve and second implant is still within the needle slot almost at the middle of sleeve.It is possible that implant was loaded in preparation for the second firing.No structural anomalies were observed on the needles or the implants.The complaint cannot be confirmed/replicated based on the received condition of the device.A manufacturing record evaluation was performed for the finished device [4l88496] number, and no non-conformances were identified.Based on provided information, we cannot discern a definitive root cause for the reported failure.At this point, 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 review = a manufacturing record evaluation was performed for the finished device [4l88496] number, and no non-conformances were identified.

• Brand Name: OMNISPAN MENISCAL REPAIR 12DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9862336
• MDR Text Key: 208024656
• Report Number: 1221934-2020-00938
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010035
• UDI-Public: 10886705010035
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 228141
• Device Catalogue Number: 228141
• Device Lot Number: 4L88496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 03/24/2020; 05/12/2020
• Supplement Dates FDA Received: 03/25/2020; 05/13/2020
• Patient Sequence Number: 1