MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7; PLATE, FIXATION, BONE

Model Number	04.501.005
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is unknown.Date of postoperative plate breakage is unknown.Date of original implant is unknown.Complainant device is not expected to be returned for manufacturer review/investigation.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 a hardware removal and revision was performed on (b)(6) 2017 due to a broken rib plate.The original procedure, a fracture at rib 6, was performed on an unknown date.Subsequently it was discovered that the plate had broken.There is no information regarding trauma or other reason for the plate breakage.It was noted that the patient is morbidly obese.Removed hardware included: one plate (broken, easily removed) and eight 2.9mm titanium locking screws -all intact.The patient was revised to a new plate and screws.Nothing untoward occurred during the procedure.No surgical delays, no fragments involved, no additional x-rays or additional medical intervention required.Routine intraoperative x-rays were taken.The procedure was completed successfully with the patient in stable condition.Concomitant devices reported: 2.9mm titanium locking screws (part #: unknown, lot #: unknown, quantity 8).This report is for one (1) ti matrixrib pre-contoured pl 17 holes for left ribs 6 & 7.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TI MATRIXRIB PRE-CONTOURED PL 17 HOLES FOR LEFT RIBS 6 & 7
• 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: 7088203
• Report Number: 2939274-2017-50168
• Device Sequence Number: 19199043
• Product Code: HRS
• UDI-Device Identifier: 10887587017006
• UDI-Public: (01)10887587017006(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 11/07/2017

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: 04.501.005
• Device Catalogue Number: 04.501.005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/06/2017
• 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