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

Catalog Number 228140

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint : (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).

Event Description

It was reported by the affiliate via email that during an acl procedure the meniscal suture technique is started and it was wanted to pass the first point to the meniscus and when the gun was activated, two stitches were skipped at the same time.The specialists stated that the product was presenting faults and decided to not use it or make suture to the meniscus and suggested that the devices be sent for quality control.The affiliate reported that the procedure was completed successfully without alternation to the patient.

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.The complaint device was received and evaluated.The complaint can be confirmed since the device was received with no implants inside the needle.A visual inspection was performed to reveal any gross visual defects that may contribute to the complaint condition, however none were observed.An unused omnispan needle assembly with the same part and lot combination was returned with the device.In an attempt to reproduce the reported failure, the unused needle was loaded onto the device.The first implant was deployed successfully with no issues after pulling the gray trigger.The second implant was then loaded into position by pulling the red trigger.Likewise, the second implant was deployed successfully with no issues after pulling the gray trigger.It is possible that the user pulled the red trigger before firing the first implant.This would cause the second implant to be loaded, and both first and second implants would remain inside the needle.Then, when the gray trigger is pulled both implants would be deployed from the needle at the same time.However, since the issue experienced by the customer could not be reproduced, no root cause can be determined for the reported failure.A non-conformance search was conducted to investigate any defects identified during production that may contribute to the complaint condition.A non-conformance was identified for this part-lot number combination, however the defect identified during processing was not related to a process which would contribute to the reported functional defect.Therefore, there is no evidence suggests that the reported defect was caused by an internal processing issue.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 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.

• Brand Name: OMNISPAN MENISCAL REPAIR, 0DEG
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8464572
• MDR Text Key: 140314248
• Report Number: 1221934-2019-56718
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705010028
• UDI-Public: 10886705010028
• 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
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 228140
• Device Lot Number: L658555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Date Manufacturer Received: 04/04/2019
• Patient Sequence Number: 1
• Patient Age: 31 YR