MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXRIB UNIVERSAL PLATE 8 HOLES; PLATE, FIXATION, BONE

Model Number	04.501.009
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.It is unknown when pain began.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 the patient underwent removal of plates and screws on (b)(6) 2018 due to pain.The patient requested removal of the three plates, screws, and five intermedullary splints as the patient was experiencing pain in the area of the implants and the patient believed the implants were the cause.The surgeon was able to remove the three plates that had been affixed with 22 screws; however, the five intermedullary splints and the five screws associated with the splints were not able to be removed.There was no surgical delay.The patient was stable after the surgery.This is report 3 of 6 for (b)(4).
Additional Manufacturer Narrative
A device history record (dhr) review was performed for part no.: 04.501.009, lot no.: 9329055, manufacturing location: (b)(4), release to warehouse date: 21.Jan.2015: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.A product investigation was performed.The ti matrixrib universal plate 8 holes (04.501.009) shows minor wear consistent with implantation and explantation.No damage was observed which may have inhibited intended device functionality.As no device defects or deficiencies were alleged it is not possible to confirm the complaint or replicate the complaint condition.Additionally, based on the allegation a drawing and dimensional analysis are not applicable as there is no indication that the device¿s design or manufacturing contributed to the reported complaint condition.A device history review, including material and hardness reviews, was performed for the returned implant¿s lot number and no mrrs, ncrs or complaint-related issues were identified with the lot number which may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.

• Brand Name: TI MATRIXRIB UNIVERSAL PLATE 8 HOLES
• 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: 7430136
• Report Number: 2939274-2018-51676
• Device Sequence Number: 1216897
• Product Code: HRS
• UDI-Device Identifier: 10887587017082
• UDI-Public: (01)10887587017082(10)9329055
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• 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): 03/22/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.501.009
• Device Catalogue Number: 04.501.009
• Device Lot Number: 9329055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Received by Manufacturer: 03/22/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 04/13/2018
• Supplement Report FDA Received Date: 05/15/2018
• 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: 67 YR