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

Catalog Number	212854
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).
Event or Problem Description
It was reported by the affiliate via email that the minilok quickanchor+ with #2 orthocord did not retain on the bone.Additional information provided by the affiliate reported the event occurred on (b)(6) 2019 and confirmed that the lot number of the device.The affiliate also reported that there was no surgical delay and the surgeon was able to complete the procedure with another anchor without any further issue.It was also reported that the device was discarded and will not be returned for evaluation.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: 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.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.No nonconformances were identified for this part number, lot number combination per qlik query executed on 5/24/2019.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.Udi: (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Further it was reported by the affiliate that the event occurred intraoperatively during fracture m5 left and screwing and reinsertion bone splinter procedure.There was no difficulty aligning instruments required for insertion prior to use.It was also reported that no excessive force needed to insert the device and there was no patient impact.

• Brand Name: MINILOK QA+ #2-0 OC 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: 8713227
• Report Number: 1221934-2019-57367
• Device Sequence Number: 14119161
• Product Code: MAI
• UDI-Device Identifier: 10886705002436
• UDI-Public: 10886705002436
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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: 02/28/2022
• Device Catalogue Number: 212854
• Device Lot Number: 3L18725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/13/2019
• Patient Sequence Number: 1