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 Problems Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Incomplete.The lot number was unknown.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.

Event Description

It was reported by the customer in (b)(6) that after a revision procedure performed on (b)(6) 2021, it was observed that there was a rupture of the wire flushed with the anchor on the gii qa+ o/c cp-2 device; and hence, there was final abandonment of the anchor.The current status of the patient post-surgery was unknown.No additional information was provided.

Event Description

It was reported by the customer in france that during a revision procedure performed on (b)(6) 2021 to an initial procedure of biceps tendon repair performed on (b)(6) 2021, the surgeon observed that there was a rupture on the thread flushed with the anchor on the gii qa+ o/c cp-2 device; and hence, there was final abandonment of the anchor; and that it remained in place in the bone.Therefore, the surgeon put a new anchor next to the old one using the same hole in the cortical bone.It was reported that upon tightening the two threads, one broke again in the anchor.The current 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 date of event and event description have been updated accordingly.

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 : 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.Given that lot number was not provided, the manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12281190
• MDR Text Key: 265178116
• Report Number: 1221934-2021-02395
• 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,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 Model Number: 222983
• Device Catalogue Number: 222983
• 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