MAUDE Adverse Event Report: SYNTHES USA; SCREW, FIXATION, BONE

Device Problem Sticking (1597)

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

Event Type  Injury  

Manufacturer Narrative

Device used for treatment, not diagnosis.Date of event: date of postoperative screw malfunction is unknown.This report is for unknown (2) 2.9mm matrixrib self-tapping locking screws/unknown lot number.Implanted date: 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.Concomitant medical product: 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).Pma/510k#: unknown.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 (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 1 of 2 for (b)(4).

Manufacturer Narrative

Device evaluated by mfr, device manufacture date: 2 unknown locking screw (2) 2.9mm matrixrib self-tapping locking screws that were reported as cold welded to the plate.The design, materials and finishing processes were found to be appropriate for the intended use of this device.No device history review was possible as the lot number is unknown.No dimensional analysis is possible as the plate is pre-contoured.No material or hardness reviews are applicable due to the device interaction allegation of cold-welded.None of the cold-welded locking screws were returned.No definitive root cause was able to be determined with the provided information.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.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7005061
• MDR Text Key: 91185418
• Report Number: 2520274-2017-12587
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

• Date FDA Received: 11/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/07/2017
• 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
• Patient Outcome(s): Required Intervention