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)

Event Date 12/11/2018

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The exp date is currently unavailable.Investigation summary: the complaint device was discarded by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.No further information regarding the procedure or the device used has been provided to determine a root cause for this failure.A non-conformance search was performed for this part#: 210712, lot#:1l58704 combination and no nonconformances were identified.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.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

This is report 2 of 2 for the same event.It was reported by the sales rep via cst that during a rotator cuff repair procedure the first lupine anchor with orthocord pulled out while attempting to insert.The sales rep stated that a mallet was not needed to fully insert the anchor, which could have been due to poor bone quality.The sales rep stated that a second lupine anchor with orthocord had the same issue.There was a five minute delay to switch anchors and complete the case.The sales rep stated that the surgeon did not use another anchor, deemed the tear could heal without the anchor.It was reported that there was no revision procedure planned.It was reported that the same bone hole was not used to complete the procedure.It was reported that the implants were removed with a grasper with no debris left behind.It was reported that there was minimal force used to pull out the anchor.The sales rep stated there was no patient harm.The anchors were discarded by the customer.There was patient involvement reported.It was not reported if there was a prolonged hospitalization.The status of the patient post-surgery was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8206214
• MDR Text Key: 131715129
• Report Number: 1221934-2018-55875
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705001101
• UDI-Public: 10886705001101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2018

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: 1L58704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR