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

Catalog Number	212032
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device was received and evaluated.Visual observation confirms that the inserter tip is bent outwards on one side.There was no damage to the anchor itself when inspected.A definite root cause cannot be determined; it is a possibility that excess torque was applied when inserting the anchor at off angle which caused the inserter tip to bend.Other than this possibility, a root cause cannot be determined.Further, a review into the depuy synthes mitek complaints system revealed no similar complaint of any kind 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.A non-conformance search was performed for this product code 212032-lot #l165772 combination and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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 etq complaint management system 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 customer that during an unspecified surgical procedure of the leg and ankle repair, it was observed that the super qa+ #2 eth cp-2 *ea device was bent when it was opened.There was no delay in the surgical procedure as an identical spare device 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.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8274124
• Report Number: 1221934-2018-53588
• Device Sequence Number: 11250931
• Product Code: JDR
• UDI-Device Identifier: 10886705001804
• UDI-Public: 10886705001804
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K930893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2017

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: 09/30/2021
• Device Catalogue Number: 212032
• Device Lot Number: L165772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2017
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2017
• Initial Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1