MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR LEFT RIBS 4 & 5; PLATE, FIXATION, BONE

Model Number	04.501.003
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight not available for reporting date of event: date of device breakage is not known.(b)(4), lot unknown.Date of implant reported as two (2) years prior to explant.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant devices therapy date reported as two (2) years prior to explant.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.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 or Problem Description
It was reported that approximately 2 years prior to removal, the patient underwent a cancer tumor resection that included removal of a rib bone and the implantation of one (1) matrixrib plate and eight (8) unknown screws.Post-operatively on an unknown date the matrixrib plate broke.The matrixrib plate was spanning a very large gap and fatigued at the point where the bone met the plate.It is unknown if patient had symptoms related to the plate failure or how the failure was detected.The patient was revised on (b)(6) 2017 and the hardware that was removed included the broken matrixrib plate and the plate fragments.In addition, eight unknown screws were removed whole and intact.There was no surgical delay reported.No harm was reported to the patient.The procedure was successfully completed.Patient outcome was reported stable.The patient was implanted with new hardware: two(2) matrixrib plates and thirteen (13) unknown screws.Concomitant devices reported: matrixrib screw (part number unknown, lot number unknown, quantity 8).This is report 1 of 1 for (b)(4).

• Brand Name: TI MATRIXRIB PRE-CONTOURED PL 16 HOLES FOR LEFT RIBS 4 & 5
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE : SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7134489
• Report Number: 2939274-2017-50383
• Device Sequence Number: 902968
• Product Code: HRS
• UDI-Device Identifier: 10887587016962
• UDI-Public: (01)10887587016962(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

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
• Operator of Device: Health Professional
• Device Model Number: 04.501.003
• Device Catalogue Number: 04.501.003
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR