MAUDE Adverse Event Report: DEPUY MITEK LLC US RGDFX CRVE ST ACL PLA XPIN SYS; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number 213013

Device Problem Break (1069)

Patient Problem Not Applicable (3189)

Event Date 02/20/2020

Event Type  malfunction  

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.(b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that during an arthroscopic repair of the anterior cruciate ligament the small wings of the rgdfx crve st acl pla xpin sys broke.There was no patient consequence, however there was a 4 minutes surgical delay reported.No additional information was provided.

• Brand Name: RGDFX CRVE ST ACL PLA XPIN SYS
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 9794381
• MDR Text Key: 193073434
• Report Number: 1221934-2020-00760
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K130105
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 213013
• Device Lot Number: 6L37958
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/20/2020
• Initial Date FDA Received: 03/05/2020
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1