MAUDE Adverse Event Report: DEPUY MITEK LLC US GII QA+ W #2 ORTHOCORD; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 222983

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).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.

Event Description

It was reported by the sales rep that during an elbow procedure the gii quickanchor+ with #2 orthocord sutures were being tied when the suture broke at the eyelet.The sales rep stated that the anchor was left in the patient and the new like-anchor was used in the same bone hole with the other anchor to complete the case.There was no surgical delay.The sales rep stated that the patient's bone quality was good.The anchor is not being returned as it is implanted in the patient.Further it was reported that the surgeon was tying knot by hand.No suture passer was used.It passed with needle provided on suture.It was also reported that no cutter was used.This is report 1 of 1 for complaint (b)(4).

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.If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The complaint device is not being returned as it was implanted in the patient, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part (222983) - lot number (2l44203) combination as per per qlik query executed 04/10/2019.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.

• Brand Name: GII QA+ W #2 ORTHOCORD
• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8524781
• MDR Text Key: 142335577
• Report Number: 1221934-2019-56877
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 222983
• Device Lot Number: 2L44203
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention