MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #4/0 ETH P-3; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	212867
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported by the customer that during a thumb repair procedure, it was observed that the customer's micro quick anchor+ with ethibond suture device broke while inserting.The customer could not provide where on the anchor it broke.The customer stated that all debris was removed from the patient.The case was completed with another like-anchor in the same bone hole with no patient harm or delay.The customer stated that no surgical intervention is planned.The customer could not provide any additional information.The anchor is being returned for evaluation.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.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and visually inspected.The anchor was not attached to the inserter.The device has been deployed.Visual inspection under magnification revealed no anomalies on the anchor or the inserter.There were no pieces of the inserter or the anchor missing which would have caused the reported failure of broken.This complaint cannot be confirmed.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.No non-conformities were identified for this part number (212867), lot number (l436501) combination.Review conducted per qlik query executed on (b)(6) 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).

• Brand Name: MICRO QA+ #4/0 ETH P-3
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8179233
• Report Number: 1221934-2018-55753
• Device Sequence Number: 16577857
• Product Code: HWC
• UDI-Device Identifier: 10886705002542
• UDI-Public: 10886705002542
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K024115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2019

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: 04/30/2022
• Device Catalogue Number: 212867
• Device Lot Number: L436501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1