MAUDE Adverse Event Report: DEPUY MITEK LLC US MENISCAL R/S APPLIER *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	228000
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.P/n: 228000; lot:3882149.The complaint device was received and evaluated.Visual observation of the applier revealed the deployment rod was slightly bent downwards which is typical of aggressively loading/removing the needle prior to/following use.The bent rod would cause deployment issues as reported.The needle was not sent back for evaluation.When tested for its functionality, the trigger functioned properly when pulled on its own without a needle attached to the device.The needle attachment key feature, which attaches the needle to the applier, had no anomalies.Further, a review into the depuy synthes mitek complaints system revealed no other similar complaints of any kind for this lot of devices that were released to distribution.A possible root cause could be a device application error.At this point in time, 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.No nonconformances were identified for this part-lot number combination per qlik query executed 1/18/2019.Review conducted per (b)(4).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.(b)(4).
Event or Problem Description
It was reported that during a meniscus repair the customers meniscal applier kept jamming.The deployment spring kept sticking when the trigger was pulled.To complete the case the surgeon opened a new meniscal applier and a new needle.There were no patient consequences or delays.This is report 1 of 2.

• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8284669
• Report Number: 1221934-2019-56194
• Device Sequence Number: 2081080
• Product Code: MAI
• UDI-Device Identifier: 10886705009930
• UDI-Public: 10886705009930
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2016

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: 11/30/2020
• Device Catalogue Number: 228000
• Device Lot Number: 3882149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2016
• Initial Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1