MAUDE Adverse Event Report: DEPUY MITEK LLC US SUPER QA+ #2 PAN CP-2 *EA; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number 212135

Device Problems Crack (1135); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Tissue Damage (2104)

Event Date 01/09/2020

Event Type  Injury  

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.(b)(4).The expiration date is unknown.This is report 3 of 4.

Event Description

It was reported by the affiliate by customer's email that during an unknown procedure the suture material of the super qa+ #2 pan cp-2 *ea torn despite the experienced pulling and knowledge of the implant.No patient consequence and no surgical delay was reported.Additional information: adequate supply of the knee extensor was not possible.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional information: b5, d10: subsequent follow-up with the customer, additional information was received.It was reported that the event occurred during complex refixation of tendon after knee tep revision.It was reported that there was an unspecified delay in the surgery.It was reported that there were three anchor body parts remained inside the patient.It was reported that the case was completed by using additional anchors.It was reported that an alternative product was not readily available.It was reported that there was no surgical intervention planned (e.G.X-rays, additional/change in procedures, prescriptions, otc, revisions) at this point; however, decisions will be made in a few weeks.It was reported that the products are not available to be returned for evaluation as they are implanted.

Manufacturer Narrative

Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: additional information: investigation summary
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> according to the information provided, it was reported that the anchor was torn during the procedure.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 [5l80121] 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.Device history lot
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> a manufacturing record evaluation was performed for the finished device [5l80121] number, and no non-conformances were identified.

• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9706048
• MDR Text Key: 179274574
• Report Number: 1221934-2020-00555
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001996
• UDI-Public: 10886705001996
• Combination Product (y/n): N
• PMA/PMN Number: K930893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 212135
• Device Catalogue Number: 212135
• Device Lot Number: 5L80121
• Date Manufacturer Received: 03/02/2020
• Patient Sequence Number: 1