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 Problem Not Applicable (3189)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Udi: (b)(4).The expiration date is not currently available.Patient identifier: (b)(6).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 2 of 2 for the same event.It was reported by the sales rep that during unspecified surgical procedure, it was observed that two lupine br ds w/orthcrd devices pulled out after they were implanted.According to the report, the event occurred after suturing bicep and tying it down.It was reported that there was 15 minute delay in the surgery.It was reported that the surgeon had pulled hard on the sutures of the two anchors to make sure they were seated properly before tying down the sutures and they held fine.However, while tying the sutures down both anchors pulled out of the bone holes.It was reported that the surgeon removed the implants and used a competitors anchors in the same two bone holes to complete the procedure with no patient consequences.The sales rep reported the two complaint devices were discarded by the surgeon.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 [4l53302] 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: 9353433
• MDR Text Key: 203902275
• Report Number: 1221934-2019-59649
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 210712
• Device Lot Number: 4L53302
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• 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