MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #0 ETH OS-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212133
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Injury (2348); Not Applicable (3189)
Date of Event	06/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported by the affiliate in (b)(4) that during a hand surgery, it was observed that two anchors failed.On the first anchor: the inserter got bent when inserted and couldn't be used since the anchor loosened from inserter.On the second anchor: the suture broke and the anchor was left inside the patient.Surgeon mentioned that the suture slided poorly in anchor.Drilling was used in normal way.Surgeon very experienced in using these anchors.Surgery was delayed of five minutes.A third anchor was used to complete the surgery successfully.There were no patient consequences.No additional information could be provided.
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.H10 additional narrative: the serial number, expiration date and device manufacture date were updated as unknown in the initial report and have been updated accordingly.Therefore, udi: (b)(4).
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.H10 additional narrative: investigation summary :according to the information provided, it was reported that on the second anchor the suture broke and the anchor was left in patient.The complaint device is still implanted in the patient, therefore unavailable for a physical evaluation.Since the complaint device remains implanted, we cannot determine a root cause for the reported failure.If the device 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 lot number:6l19140, 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.

• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10207128
• Report Number: 1221934-2020-01687
• Device Sequence Number: 11292927
• Product Code: HWC
• UDI-Device Identifier: 10886705001972
• UDI-Public: 10886705001972
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K992487
• 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): 06/11/2020

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: 212133
• Device Catalogue Number: 212133
• Device Lot Number: 6L19140
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 08/13/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/06/2020; 08/14/2020
• Patient Sequence Number: 1