MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 ETH V-4; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 212865

Device Problem Mechanical Jam (2983)

Patient Problem Injury (2348)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).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 and lot 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.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

Event Description

It was reported by the affiliate in (b)(6) that the plastic sleeve at the inserter would not slide so that the anchor could not be implanted to bone hole during an unspecified surgical procedure.It was reported that the surgery was completed by using another device and by recreating the bone hole at different position.It was reported that the device was brand new and it was the first usage when the issue occurred.There was no surgical delay and no harm to the patient reported.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: MICRO QA+ #3/0 ETH V-4
• Type of Device: SOFT-TISSUE ANCHOR, NON-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: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7996280
• MDR Text Key: 124729413
• Report Number: 1221934-2018-55024
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886705002528
• UDI-Public: 10886705002528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K024115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2018

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 Expiration Date: 01/31/2022
• Device Catalogue Number: 212865
• Device Lot Number: L290988
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 10/23/2018
• 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