MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #0 ETH OS-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212133
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.The complaint device was received and evaluated.Visual observation reveals that the anchor positioned at the tip of the inserter is not aligned/bent to the inserter shaft.There were stains near the inserted distal end and even the suture is discolored near the anchor confirming that this is not an out of the box failure and the device has been used.So, the reported failure cannot be confirmed.To investigate further, the anchor was removed from the tip and it was noticed that the inserter tip was bent which caused the anchor to look bent.Inserter tip bent might be caused due to off-axis insertion, levering during insertion or hard bone quality.A dhr review has been conducted and the results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy synthes mitek complaints system revealed no other complaint for this lot of devices that were released to distribution.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.Udi: (b)(4).
Event or Problem Description
Anchor tip bend.It was noted that tip of anchor bent when out of package.Changed the new one to complete.There was no adverse event on patient report.
Additional Manufacturer Narrative
Product complaint # (b)(4).Missed to enter 510(k) number k992487 in the initial medwatch.Hence submitting follow-up medwatch to update the information.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7499845
• Report Number: 1221934-2018-50608
• Device Sequence Number: 13480879
• Product Code: HWC
• UDI-Device Identifier: 10886705001972
• UDI-Public: 10886705001972
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K992487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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: 08/31/2022
• Device Catalogue Number: 212133
• Device Lot Number: L553148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2018
• Initial Date Received by Manufacturer: 05/09/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 05/09/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1