MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ #2-0PAN RB-1; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number	212852
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, a review into the depuy synthes mitek complaints system revealed no similar and no dissimilar complaints for this lot of devices with the product code that were released to distribution.Nc review has been conducted and no nonconformances were identified for this product code combination.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.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.No nonconformances were identified for this product code per query.
Event or Problem Description
This is report 2 of 2 for the same event.It was reported by the sales rep that two of the customer's minilok qa plus 2/0 with panacryl would not seat in the bone hole during a hand procedure.The case was completed with another like device.No new bone hole needed to be created.There were no patient consequences or delays.The sales rep was not present during the case and could not provide any more details.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: MINILOK QA+ #2-0PAN RB-1
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7974459
• Report Number: 1221934-2018-54973
• Device Sequence Number: 1739099
• Product Code: MAI
• UDI-Device Identifier: 10886705002412
• UDI-Public: 10886705002412
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/29/2017

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: 08/31/2020
• Device Catalogue Number: 212852
• Device Lot Number: L529038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2017
• Initial Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1