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

Catalog Number 210712

Device Problems Break (1069); Migration or Expulsion of Device (1395)

Patient Problems Injury (2348); Not Applicable (3189)

Event Date 02/07/2019

Event Type  Injury  

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.Investigation summary: the complaint device is not being returned.It was discarded by the customer therefore not available for a physical evaluation.We cannot determine what caused the user to experience the reported event; we cannot discern a root cause for the reported failure mode.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination.Review conducted per qlik query executed (b)(6) 2018.At this point in time, no corrective action is required, and no further action is warranted.However, depuy (b)(4) 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.

Event Description

It was reported by the sales rep via cst that during a shoulder repair procedure the lupine anchor with orthocord was slightly pulled to set the anchor when the anchor pulled out from the bone.The sales rep stated that the pilot hole was drilled and the anchor was being inserted down the drill guide when the surgeon slightly pulled on the anchor.Once it pulled out from the bone, the sales rep stated they noticed the anchor was broken in half and fragments were created, but these were removed without additional surgical intervention.The sales rep was not certain if breakage occurred from malleting the anchor into the bone or if it was a faulty product from the beginning.The case was completed with another anchor with no patient harm, but a five minute delay to open the new anchor.The device was discarded by the customer.Additional information provided by the sales rep reported that all fragments were removed from the patient with a grasper.A new bone hole created to complete the case and patient's bone quality was good.

• 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: 8387912
• MDR Text Key: 137790368
• Report Number: 1221934-2019-56558
• 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,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2019

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: 2L25190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2019
• Initial Date FDA Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1