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).The lot number was unknown.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.

Event Description

It was reported by the customer in (b)(6) 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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6013142063
• MDR Report Key: 12439341
• MDR Text Key: 270309348
• Report Number: 1221934-2021-02652
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705008612
• UDI-Public: 10886705008612
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention