MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ O/C CP-2 *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number 222983

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/12/2021

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Investigation summary: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (7l29153), and no non-conformances related to the reported complaint condition were identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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 Description

It was reported by the customer in (b)(6) that after an initial procedure on (b)(6) 2020, it was observed that a wire broke in the mitek g ii qa + ( orthocord ) device; and it was not avulsion.It was reported that the surgery failed and the suture was released postoperatively which led to a revision surgery on (b)(6) 2021.The status of the patient post-surgery was unknown.No additional information was provided.

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: subsequent follow-up with the customer, additional information was received regarding the event.Therefore, the event description has been updated accordingly.H10 correction narrative: based on the additional information received, the date of event and health effect - impact code have been updated to reflect the correct information.

Event Description

It was reported by the customer in france that after an initial procedure of reinsertion of the distal tendon on radius / elbow on (b)(6) 2020 for an observation of a secondary release, it was observed through ultrasound and mri that a wire broke in the mitek g ii qa + (orthocord) device; and it was not avulsion.It was reported that the surgery failed and the suture was released postoperatively.The surgeon decided to not operate again but wondered how this release could have occurred as he carried out a double lacing of two anchors with several trans-tendinous passages (orthocord thread).The event date was unknown.The current status of the patient was unknown.No additional information was provided.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12283131
• MDR Text Key: 265256029
• Report Number: 1221934-2021-02404
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705008612
• UDI-Public: 10886705008612
• Combination Product (y/n): N
• PMA/PMN Number: K051989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 222983
• Device Catalogue Number: 222983
• Device Lot Number: 7L29153
• Date Manufacturer Received: 08/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention