MAUDE Adverse Event Report: DEPUY MITEK LLC US VERSALOK PRE PACKED W/OC; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 210808

Device Problem Difficult to Remove (1528)

Patient Problem Injury (2348)

Event Date 11/22/2018

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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 affiliate in (b)(6) "during that" the versalok pre packed w/oc could not be removed after anchor implant in rotator cuff repair.It was reported that the bone got damaged upon removal of the implant.The surgeon opened a new bone hole in order to complete the procedure with a new device.As a result, there was a surgical delay of one hour in the surgical procedure.It was reported that the patient is currently being monitored at the hospital.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Additional information received from the affiliate on 12/13/2018 reporting that it is unknown where the implant broke or bent.It is unknown how many pieces the implant broke into.It was also reported that the implant and debris were removed from the patient.The patient's bone quality was reported to be good and that the doctor was not off axis while inserting the implant.The device will be returning for evaluation.

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

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.Evaluation statement: the complaint device was received and inspected.The complaint can be confirmed.The anchor was observed to be stuck on the inserter with the sutures attached.A visual observation revealed that some suture was twisted in between the anchor and the titanium pin and the peek sleeve.It is possible that the sutures were not configured correctly before deploying the anchor.This may have happened when loading the sutures in which case the sutures may not have been threaded through completely therefore having an excess in suture length between the pin and sleeve.Another opportunity for the suture to become twisted between the pin and sleeve is during the tensioning step in which case the suture may have been re-positioned due to the tension applied if the anchor was not fully seated first.However, given the information provided we cannot discern a definitive root cause for the reported failure.A non-conformance search was conducted to investigate any defects during production identified that may contribute to the complaint condition.No non-conformance was identified for this part-lot number combination.At this point, 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.Udi: (b)(4).

• Brand Name: VERSALOK PRE PACKED W/OC
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8147201
• MDR Text Key: 129796865
• Report Number: 1221934-2018-55613
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705001224
• UDI-Public: 10886705001224
• Combination Product (y/n): N
• PMA/PMN Number: K063478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 210808
• Device Lot Number: L790035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Date Manufacturer Received: 12/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention