MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE BR DS W/ORTHCRD; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 210712

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); Not Applicable (3189); No Code Available (3191)

Event Date 10/21/2019

Event Type  Injury  

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.(b)(4).The expiration date is not currently available.(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

This is report 1 of 2 for the same event.It was reported by the sales rep via cst tool that during a labral repair surgical procedure, while utilizing mitek lupine br dual suture anchors with orthocord, it was observed that the anchor pulled out of the bone as the surgeon attempted to seat the anchor.According to the reporter, the event occurred upon attempting to place the first anchor and after the drill hole had been made.It was reported that the bone quality appeared suspect but the anchor failed nonetheless.It was reported that later on in the case, as the surgeon was attempting to place another anchor in a new location, the hole was drilled and he attempted to place the anchor down the hole.However, as he started to mallet the anchor into place, it was observed that the distal tip of the anchor had snapped and deemed the anchor useless.It was reported that the anchor was taken out and all fragments were recovered.Another anchor was opened and placed successfully and the case went on without further delay.The procedure was completed with new anchors with no patient harm but there was five minute surgical delay to the case.It was reported that the same hole was used and redrilled.It was reported that there were no debris left in the patient.It was reported that the type of force used when the anchor was pulled out was standard force.There was a delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device [5l45092] number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.Udi: (b)(4).The expiration date is unknown.

• Brand Name: LUPINE BR DS W/ORTHCRD
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9347635
• MDR Text Key: 167184480
• Report Number: 1221934-2019-59612
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/22/2019

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 Catalogue Number: 210712
• Device Lot Number: 5L45092
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention