MAUDE Adverse Event Report: DEPUY MITEK LUPINE LOOP RAPIDE ANCHOR W/ORTHOCORD DS; MITEK ANCHOR IMPLANTS

Catalog Number 210712

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).The lot expiration date is currently unavailable.

Event Description

The sales rep reported that during a shoulder procedure once the customer's lupine br anchor with orthocord dual suture was implanted, the sutures detached from the anchor.The sales rep stated that the sutures tore and that the surgeon was not using excessive force.The sales rep stated that the surgeon is very well experienced in using the device and hasn't had this happened before.The sales rep stated that the anchor was left in and the sutures were discarded.The sales rep reported that the surgeon completed the procedure with another like device by creating a new bone hole with no further issues.The sales rep reported that there were no patient consequences but there was a five minute delay in the case.No device will be returning for evaluation.

Manufacturer Narrative

The complaint device is not available for a physical evaluation.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.Depuy 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 LOOP RAPIDE ANCHOR W/ORTHOCORD DS
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808210
• MDR Report Key: 5787573
• MDR Text Key: 49367805
• Report Number: 1221934-2016-10271
• Device Sequence Number: 1
• Product Code: MAI
• 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
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 210712
• Device Lot Number: 3855963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2016
• Initial Date Manufacturer Received: 06/13/2016
• Initial Date FDA Received: 07/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other