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

Catalog Number 210711

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2019

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on (b)(6) 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.

Event Description

It was reported by the affiliate in (b)(6) via e-mail that the lupine br with orthocord was defective.It would not hold on the bone.There was no patient impact or delay in surgery reported.Another device was used to complete the surgery.There was no delay in surgery or patient impact for this incident.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.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, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part number, lot number combination per qlik query executed on 05/30/2019.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.Udi: (b)(4).

• Brand Name: LUPINE BR 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: 8655501
• MDR Text Key: 146661225
• Report Number: 1221934-2019-57253
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001095
• UDI-Public: 10886705001095
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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 Expiration Date: 12/31/2021
• Device Catalogue Number: 210711
• Device Lot Number: 3L05669
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/30/2019
• Supplement Dates Manufacturer Received: 06/03/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1