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

Model Number	212867
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, it was reported by the affiliate via cst that the micro qa+ #4/0 eth p-3 was missing a tip and could therefore not be used.The facility requires a replacement unit.No patient consequence.No surgical delay.This report is for one (1) micro qa+ #4/0 eth p-3.This is report 1 of 1 for (b)(4).
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi:((b)(4).
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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was received and evaluated.Visual observations revealed the anchor is off the inserter but held in place by the suture.Upon observing under magnification, no anomalies were noted on the anchor.However, the pin on distal end of the inserter tip appears to be bent outwards on one side.This sleeve holds the anchor in place.This complaint can be confirmed.It is possible that excessive force was applied while deploying the anchor causing the sleeve to bent.Other than the possibility of this occurrence, we cannot determine a root cause for this failure.No components missing were noted.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device lot number 3l05819, and no non-conformances related to the reported complaint condition were identified.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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).The expiration date is unknown.

• 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: 9226387
• Report Number: 1221934-2019-59173
• Device Sequence Number: 1934772
• Product Code: HWC
• UDI-Device Identifier: 10886705002542
• UDI-Public: (01)10886705002542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024115
• 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,Followup
• Report Date (Section B): 09/27/2019

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 Model Number: 212867
• Device Catalogue Number: 212867
• Device Lot Number: 3L05819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 12/16/2019; 01/17/2020
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 12/17/2019; 01/21/2020
• Patient Sequence Number: 1