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

Catalog Number 212034

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Not Applicable (3189)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4), incomplete.The lot number is unknown.

Event Description

It was reported by the affiliate that during a patellar ligament suturing procedure.Three pieces of the gii qa anchor had a broken suture.The procedure was delayed for more than 30 minutes.The devices were brand new and the first use when the issue occurred.There was no harm to the patient.Additional information provided by the affiliate reported the following: after the surgeon made a burr hole, s/he inserted the 1st anchor per the surgical instruction and confirmed that the anchor had been fixed without the suture breakage.While the surgeon was threading the suture in the patient¿s body, the 1st thread broke.Next, the surgeon inserted the 2nd anchor into the same burr hole very carefully and checked if any breakage could be noticeable by sliding the suture.This time, however, the suture broke again during suturing in the patient¿s body.S/he commented that the 2nd suture did not catch in any sharp bone area.Finally, the 3rd anchor was used, and this anchor had no issue.The rest of the procedure was completed.The first two anchors remain in the patient¿s body.The broken sutures will be returned to you for your inspection to find possible causes for the breakage.It was later reported by the affiliate reporting lot numbers l746362 and l863080 were used during the procedure but could not clarify which lot belonged to a particular device.The affiliate reported the anchors will be returned for evaluation.

Manufacturer Narrative

Synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report depuy 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.The suture of the device was only returned and evaluated.Visual observation reveals suture is broken as reported.This complaint can be confirmed.Since the anchor was not returned it is possible that inserter shaft was consistent with applying excessive force while inserting the anchor beyond its intended use causing it to bend and suture to snap.The root cause for the reported could be attributed to user technique error.However,the definitive root cause cannot be determined.A non-conformance search was performed and no non-conformances were identified for this part and lot number combination per qlink search performed on (b)(6) 2019.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.A non-conformance search was performed and no non-conformances were identified for this part and lot number combination per qlink search performed on (b)(6) 2019.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

The affiliate reported additional information could not be provided.

Manufacturer Narrative

Product complaint #: (b)(4).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.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8916947
• MDR Text Key: 155190042
• Report Number: 1221934-2019-58076
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 10886705001828
• UDI-Public: 10886705001828
• Combination Product (y/n): N
• PMA/PMN Number: K915889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 212034
• Device Lot Number: L746362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Date Manufacturer Received: 10/21/2019
• Patient Sequence Number: 1