MAUDE Adverse Event Report: DEPUY MITEK GRYPHON P BR ANCHOR W/ORTHOCORD; MITEK ANCHOR IMPLANTS

Catalog Number 210814

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 06/12/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 dhr 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.(b)(4).

Event Description

The sales rep reported via phone that the gryphon p br anchor with orthocord unloaded during a labrum repair.The rep stated this was a physician error as the sutures were erroneously removed.The case was completed with a new bone hole and another like device.The reported device was left inside the patient.There were no adverse patient consequences with a two-minute delay.The sales rep stated the device will not be returned as it's inside the patient.

• Brand Name: GRYPHON P BR ANCHOR W/ORTHOCORD
• Type of Device: MITEK ANCHOR IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6700017
• MDR Text Key: 79580164
• Report Number: 1221934-2017-10345
• 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
• Report Date: 06/12/2017

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: 01/31/2020
• Device Catalogue Number: 210814
• Device Lot Number: L281855
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2017
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• 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