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

Catalog Number	228140
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint needle was received and evaluated.Visual inspection of the needle revealed the needle was bent at an unintended angle.The deployment rod of the applier was jammed inside the needle, causing the needle to be stuck on the applier.A greater amount of force was required to remove the needle from the applier.Further inspection revealed that both implants were absent from the needle.The bent needle can be attributed to excessive force on the device while attempting to maneuver it into position or the customer attempting remove the stuck needle from the applier with excessive force.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.Further, a review into the depuy synthes mitek complaints system revealed 2 other dissimilar complaints for this lot of devices that were released to distribution.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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the applicator on the omnispan meniscal repair, 0 deg device did not fire the second stitch.It was reported that the first implant was left implanted, no problem related to the first fire.It was necessary to open a new suture to complete the procedure.According to the reporter, in order to solve the problem, it was necessary to open new suture.It was reported that when changing the load, the same problem occurred and it continued not firing the second point.It was reported that the surgeon had enough experience with handling the product requested authorization to send the product for analysis.There was no harm to the patient and the surgery did not exceed time longer than 30 minutes.It was reported that the same location on the meniscus was used to complete the procedure.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.

• Brand Name: OMNISPAN MENISCAL REPAIR, 0DEG
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8271299
• Report Number: 1221934-2018-53293
• Device Sequence Number: 1685791
• Product Code: MAI
• UDI-Device Identifier: 10886705010028
• UDI-Public: 10886705010028
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/03/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 228140
• Device Lot Number: 3759694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 01/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1