MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXRIB PRE-CONTOURED PL 18 HOLES FOR LEFT RIBS 8 & 9; PLATE, FIXATION, BONE

Model Number	04.501.007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device malfunctioned intra-operatively and was not implanted / explanted complainant part is not expected to be returned for manufacturer review/investigation.Patient code used for: the surgeon was unable to remove the screws from the plate requiring to rib to be cut to remove the construct.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.Investigation summary: dhr review could not be conducted due the insufficient information¿s.Product was not returned and no lot number was provided.Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent a hardware removal procedure on friday (b)(6) 2018 due to loosing screws.During the removal surgery, as the surgeon attempted to remove the plate from the rib, it was discovered that one of the screws had stripped into the plate, binding them together.This discovery caused a 5 minute delay in surgery, as the surgeon attempted to separate the screw from the plate.Unfortunately, the surgeon was unable to separate the two devices and had to cut out the patient¿s rib in order to remove the hardware.All the screws and the plate were removed during the (b)(6) 2018 procedure.This report involves 2 devices.This report is 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Device was implanted on an unknown day in (b)(6) of 2015.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 & 9
• 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: 7398106
• Report Number: 2939274-2018-51460
• Device Sequence Number: 128451
• Product Code: HRS
• UDI-Device Identifier: 10887587017044
• UDI-Public: (01)10887587017044(10)LOTNUMBER
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2018

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: 04.501.007
• Device Catalogue Number: 04.501.007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 05/02/2018
• 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: 57 YR
• Patient Weight: 77