MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE; PLATE, FIXATION, BONE

Catalog Number 04.501.208.01S

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that on may (b)(6) 2020, 5 matrixrib locking screws were noticed to have pulled off of 2 matrixrib plates.The reported screws pulled away from the bone.The issue was discovered via imaging the next day after the procedure.Initially, the reported screws were implanted on (b)(6) 2020.The surgeon decided not to revise issue.There was no patient consequence reported.Concomitant devices reported: ti matrixrib pre-contoured plate 18 holes for left ribs 8 & 9 (part # 04.501.007, lot # unknown, quantity 2); 2.7mm ti matrixrib locking screw self-drilling/8mm-sterile (part # 04.501.208.01s, lot # unknown, quantity 4).This report is for 1 2.7mm ti matrixrib locking screw self-drilling/8mm-sterile this is report 5 of 5 for complaint (b)(4).

• Brand Name: 2.7MM TI MATRIXRIB LCKNG SCREW SELF-DRILLING/8MM - STERILE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10153933
• MDR Text Key: 195137414
• Report Number: 2939274-2020-02799
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10887587073477
• UDI-Public: (01)10887587073477
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190409
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.501.208.01S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 2.7MM TI MATRIXRIB LCKNG SCREW 8MM; 2.7MM TI MATRIXRIB LCKNG SCREW 8MM; 2.7MM TI MATRIXRIB LCKNG SCREW 8MM; 2.7MM TI MATRIXRIB LCKNG SCREW 8MM; TI MATRIXRIB PRE-CONTOURED PL 18 HOLES; TI MATRIXRIB PRE-CONTOURED PL 18 HOLES