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

Catalog Number 228140

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4) - incomplete.The exp date is currently unavailable.The complaint device was received and evaluated.Visual observation confirms that only the needle without implants was received.The needle was examined under magnification, and no structural anomalies were found that would have contributed in the reported failure.One possible hypothesis for the reported failure is that the bent main pusher rod prevented the loading rod from advancing inside the needle, causing it to stuck and cause the deployment issue.It cannot be determined at what point in time this failure occurred.We cannot discern a root cause for this failure at the time of this investigation.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.Based on the overall complaint rate, at this point in time, no further action is warranted.However, 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.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

This is report 2 of 2 for the same event.It was reported by the affiliate in (b)(6) that during mensical repair surgical procedure, it was observed that when the first point of the suture was placed, the suture fired properly and when shooting with the red trigger to advance the next point, the second point of the suture did not advance.There was no delay in the procedure which was completed by the surgeon using another device.The needle was loaded in the correct orientation.The surgeon used the same location for the second implant.The red trigger of the gun did not move when depressed and the there surgery group did hear a 'click'.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.Correction: h10: investigation summary: the nonconformance search/query statement was inadvertently missed in the investigation summary section on the initial report.The updated investigation summary is as follows: investigation summary: the complaint device was received and evaluated.Visual observation confirms that only the needle without implants was received.The needle was examined under magnification, and no structural anomalies were found that would have contributed in the reported failure.One possible hypothesis for the reported failure is that the bent main pusher rod prevented the loading rod from advancing inside the needle, causing it to stuck and cause the deployment issue.It cannot be determined at what point in time this failure occurred.We cannot discern a root cause for this failure at the time of this investigation.A review into the mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.Based on the overall complaint rate, at this point in time, no further action is warranted.However, 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.A non-conformance search was performed and no non-conformances were identified for the part/lot number combination.This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

• 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: 8252299
• MDR Text Key: 134073943
• Report Number: 1221934-2018-50864
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

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 Catalogue Number: 228140
• Device Lot Number: 3785426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2015
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 01/16/2019
• Supplement Dates Manufacturer Received: 01/29/2019
• Supplement Dates FDA Received: 01/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1