MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #4/0 ETH C-1; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.(b)(4).
Event or Problem Description
It was reported by affiliate via complaint submission tool that during hand surgery, micro qa+ #4/0 eth c-1, the part that connected between suture and suture needle is broken.No patient consequences or surgical delay reported.The device is available to be returned for evaluation.Additional information received from the affiliate reported the event occurred during suturing of the patient's finger.It was reported as soon as the surgeon was aware of the reported issue a new device was used to complete the procedure.The affiliate reported patient harm or delay did not occur.
Additional Manufacturer Narrative
Additional narrative: investigation summary = > according to the information provided, it was reported that during hand surgery, micro qa+ #4/0 eth c-1, the part that connected between suture and suture needle is broken.The complaint device was received and evaluated.Visual observation reveals that the anchor is off the inserter but still intact and held in place by the suture and no anomalies were found into the inserter.The suture was broken off from the needle; thus, confirming this complaint.The reported failure stated when surgeon sutured finger and the photo provided by the customer showed the same failure found.The possible root cause could've been suture tangled, there's a possibility that tried to remove and somehow the tangled suture pulled on the needles which eventually could've broken off the suture, releasing the needle.However, it cannot be conclusively affirmed.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.
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 the information is unknown, not available or does not apply, the section/field of the form is left blank.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).

• Brand Name: MICRO QA+ #4/0 ETH C-1
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10006827
• Report Number: 1221934-2020-01256
• Device Sequence Number: 480862
• Product Code: HWC
• UDI-Device Identifier: 10886705002535
• UDI-Public: 10886705002535
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K024115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2020

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: 08/31/2024
• Device Model Number: 212866
• Device Catalogue Number: 212866
• Device Lot Number: 6L10165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 05/18/2020; 06/16/2020
• Initial Report FDA Received Date: 04/28/2020
• Supplement Report FDA Received Date: 05/21/2020; 06/16/2020
• Patient Sequence Number: 1