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 Codes	Component Missing (2306); Residue After Decontamination (2325)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: according to the information provided, it was reported by affiliate via complaint submission tool that during surgery, micro qa+ #4/0 eth c-1, suture anchor x2 did not work.The complaint device was received and evaluated.Visual observations confirm that the anchor, suture, needles and the cover were not received in the package to be evaluated, the sleeve and the drill were received in good conditions.In addition, the device presented biological residues.This complaint cannot be confirmed.The possible root cause for the reported failure can be attributed to the low tension applied in the suture.However, this cannot be conclusive determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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.
Event or Problem Description
It was reported that during an unknown surgery, it was observed that the micro qa+ #4/0 eth c-1 did not work.During in-house engineering evaluation, it was determined that the anchor, suture, needles and the cover were not received in the package to be evaluated and the device presented biological residues.There was no delay in the surgical procedure.New anchors were used to complete the surgery successfully.There were no fragments generated.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• 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: 10189658
• Report Number: 1221934-2020-01615
• Device Sequence Number: 3408420
• Product Code: HWC
• UDI-Device Identifier: 10886705002535
• UDI-Public: 10886705002535
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K024115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 10/31/2022
• Device Model Number: 212866
• Device Catalogue Number: 212866
• Device Lot Number: L658498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1