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

Catalog Number 228141

Device Problems Entrapment of Device (1212); Failure to Advance (2524)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 04/18/2019

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Reporter's complete address was not provided.(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

It was reported by the affiliate in (b)(6) that during a meniscorrhaphy procedure the omnispan meniscal repair 12 degree would not tighten the suture.According to the report, the event occurred after firing two plates.I it was reported that scissors were used to cut the tissue but the two plates could not be retrieved and remained in the patient.Another device was used to complete the surgery.There was about a thirty minute surgical delay.It was reported that the patient's status post-surgery was stable but still in the hospital.It was reported that the surgeon was not off axis.It was reported that the same bone hole was used to complete the procedure.All available information has been disclosed.If additional information should become available, a supplemental medwatch report 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.The complaint device is not being returned, therefore unavailable for a physical evaluation.However ,there two videos available.As per the visual inspection from the video 1, omnispan meniscal repair 12 degree would not tighten the suture confirming the complain condition.From the second video it was observed that the device that couldn't be fully inserted confirming the complaint.However,from the video available there are no signs of foreign body left in the patient,which cannot be confirmed.Since the reported condition foreign body left in the patient cannot be confirmed the root cause for the cannot be determined.However,the root cause for the devices that cannot be inserted or seated can be due user handling of the device.However,definitive root cause cannot be determined.A non-conformance search was performed and no non-conformances were identified for this part number (228141) with lot number (1l29582 ) combination per qlink search performed on 07/18/2019.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.Udi:(b)(4).

• 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: 8594702
• MDR Text Key: 144540539
• Report Number: 1221934-2019-57099
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 228141
• Device Lot Number: 1L29582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Manufacturer Received: 04/22/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention