MAUDE Adverse Event Report: DEPUY MITEK LLC US OMNISPAN MENISCAL REPAIR 27DEG; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 228142

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This is report 2 of 3 for the same event.It was reported by the affiliate in (b)(6) that during an anterior cruciate ligament (acl) surgical procedure of the left knee, it was observed that the omnispan meniscal repair 27 deg device did not fire again after the first firing.It was reported that another omnispan meniscal repair 27 deg device was obtained but the failure happened again.This occurred one more time until the fourth omnispan meniscal repair 27 deg device was used to complete the procedure.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).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.Udi: (b)(4).

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.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.Investigation summary: total three needles and two sutures were received separately.All the returned devices were evaluated visually.The needles cannot be distinguished as the batch/ lot number is not printed/etched on the devices.Visual observations on one of three needles shows that it has one puncture/hole at the proximal end of the silicon sleeve.Both implants are missing but suture was received visual observations on second needle shows that it has two punctures/holes.One hole is at the proximal end of the silicon sleeve and second hole is almost at the middle of the silicon sleeve.Its missing both implants but suture was received visual observations on third needle shows no defects as its received intact.Its missing both implants and suture.The complaint can not be confirmed for the will not fire / deploy condition based on received condition of devices.Since the gun is discarded, we cannot discern any definite root cause at this point of time.No structural anomalies were observed on the needles or the implants.A manufacturing record evaluation was performed for the finished device [3l39712] number, 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 review : a manufacturing record evaluation was performed for the finished device [3l39712] number, and no non-conformances were identified.

• Brand Name: OMNISPAN MENISCAL REPAIR 27DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9480974
• MDR Text Key: 208721250
• Report Number: 1221934-2019-60002
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010042
• UDI-Public: 10886705010042
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 228142
• Device Catalogue Number: 228142
• Device Lot Number: 3L39712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Date Manufacturer Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1