MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROQA+W/#4OC(C1); SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212041
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2020
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.Investigation summary: the device was received in open condition.Upon visual inspection it was noticed that the one of the distal prongs of the plastic sleeve was found to be deformed outside.The complaint can not be confirmed for the upon receipt -device damaged as device was received in open condition.A manufacturing record evaluation was reviewed, no non-conformances were identified for the reported part 212041- lot l658501 number combination.Based on given information provided we cannot discern a definitive root cause for the reported failure.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.(b)(4).
Event or Problem Description
It was reported by the customer that the tip of the anchor was already broken in the packaging.The procedure was completed with same like product; no harm nor surgical delay.

• Brand Name: MICROQA+W/#4OC(C1)
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10059432
• Report Number: 1221934-2020-01380
• Device Sequence Number: 19656642
• Product Code: HWC
• UDI-Device Identifier: 10886705001873
• UDI-Public: 10886705001873
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2020

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: 10/31/2020
• Device Model Number: 212041
• Device Catalogue Number: 212041
• Device Lot Number: L658501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1