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

Model Number	212045
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).
Event or Problem Description
It was reported by sales rep via complaint submission tool as follows: during extensor tendon repair, as the doctor went to insert the anchor the shaft attaching the anchor to the inserter broke off.The surgery was completed with another anchor.The device is available for evaluation.Additional information received from the affiliate reported fragments were generated but all pieces were recovered.There was a 5 minute surgical delay but no complication to the patient was reported.It was also stated that the device was discarded by the facility and cannot be returned for an evaluation.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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 = > according to the information provided, it was reported that during extensor tendon repair, the shaft attaching the anchor to the inserter broke off.The complaint device was discarded by the customer, therefore unavailable for a physical evaluation.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.A manufacturing record evaluation was performed for the finished device [l982494] number, and no non-conformances were identified.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.

• Brand Name: MICRIFXQA+ W/#4OC C1
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10814379
• Report Number: 1221934-2020-03394
• Device Sequence Number: 13731560
• Product Code: MAI
• UDI-Device Identifier: 10886705001903
• UDI-Public: 10886705001903
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2020

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: 07/31/2021
• Device Model Number: 212045
• Device Catalogue Number: 212045
• Device Lot Number: L982494
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 11/23/2020
• Patient Sequence Number: 1