MAUDE Adverse Event Report: SYNTHES MEZZOVICO TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 &; PLATE,FIXATION,BONE

Catalog Number 04.501.007

Device Problem Sticking (1597)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369)

Event Type  Injury  

Manufacturer Narrative

Patient information is not available for reporting.Date of postoperative plate breakage is unknown.(b)(4), (10) lot number unknown.Implanted approximately three-five (3-5) years ago, exact date is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Therapy date is approximately three-five (3-5) years ago.Concomitant devices: 2.9mm matrixrib self-tapping locking screws (item number unknown, lot number unknown, quantity 10 each), ti matrixrib pre-contoured plates 18 holes for left ribs 8 & 9 (item number 04.501.007, lot number unknown, quantity 1 each).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 the patient had original surgery approximately three-five (3-5) years ago for treatment to the eighth and ninth left ribs due to a fracture sustained in a motorcycle accident.Patient was originally implanted with two (2) ti matrixrib pre-contoured plates; one plate on each broken rib, and twelve (12) 2.9mm matrixrib self-tapping locking screws.A total of six (6) screws were implanted in each rib plate.Screw length on each of the screws are unknown.On an unknown date post-operatively, patient presented with a non-union at both the eighth and ninth left rib bones.Also, it was reported the patient had one (1) broken plate.Plate was reported broken in the middle of the plate, not at a screw hole position.It is unknown which rib bone the broken plate was present on.(this event captured on (b)(4)).On (b)(6) 2017, surgeon removed all implants and performed a rib resection on both ribs.During the revision procedure, as the surgeon was attempting to remove the screws from the intact plate, two (2) 2.9mm screws were reported as cold welded to the plate.This necessitated cutting the plate out.(this event captured on com-(b)(4).No plate fragments remained and no additional x-rays were required.No additional implant hardware were used.Surgery was completed successfully and patient is reported in stable condition.All implants will be returned to customer quality for evaluation.This report is for two (2) devices concomitant devices: 2.9mm matrixrib self-tapping locking screws (item number unknown, lot number unknown, quantity 10 each).Ti matrixrib pre-contoured plates 18 holes for left ribs 8 & 9 (item number 04.501.007, lot number unknown, quantity 1 each).This report is 2 of 2 for (b)(4).

Manufacturer Narrative

Date returned to manufacturer.Subject device has been received and product development investigation was completed.The report indicates that: the returned plate was examined and the complaint was able to be confirmed as the device was found to be broken at the 8th hole.Additionally, the plate was cut after the 11th hole, likely prior to implantation.No definitive root cause was able to be determined with the provided information.The ti matrixrib pre-contoured plate, 18 hole (04.501.007) is available in the matrixrib system which is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone.The returned plate was examined and the complaint was unable to be confirmed as no screws were returned cold-welded to the plate and no significant post-manufacturing damage was observable at the screw holes.The plate was found to be broken through the 8th hole and cut after the 11th hole.Based on the complaint description it is likely that the cut and break occurred while attempting to remove the plate during the revision procedure.None of the cold-welded locking screws were returned.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection, complaint history review, drawing review, and risk assessment review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is unconfirmed.Device 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.

• Brand Name: TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 &
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer (Section G): SYNTHES MEZZOVICO; zona industriale 4; mezzovico CH680 5; SZ CH6805
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7005095
• MDR Text Key: 91208088
• Report Number: 1000562954-2017-10242
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161590
• 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: 10/11/2017

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.501.007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/06/2017
• Supplement Dates Manufacturer Received: 11/07/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention