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	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2021 during an unknown procedure, one (1) matrix rib 17 hole plate and one (1) matrix rib 18 hole plate were explanted from the patient due to breakage and nonunion.The date of the initial implant surgery is unknown.There were no fragments found in the patient.The patient and procedure outcome was unknown.Concomitant device reported: ti matrixrib im splint medium-4mm width (part# 04.501.011; lot# unknown; quantity: 1); 2.9 ti matrixrib lckng screw stping/12 (part# 04.501.022.01, lot# unknown; quantity: 1); 2.9 ti matrixrib lckng screw stping/14 (part# 04.501.024.01, lot# unknown; quantity: 1); unk - screws: matrixrib (part# unknown; lot# unknown; quantity: 11).This report is for one (1) ti matrixrib pre-contoured pl 17 holes for left ribs 6 & 7.This is report 1 of 2 for (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: 12228130
• Report Number: 2939274-2021-04283
• Device Sequence Number: 4062768
• Product Code: HRS
• UDI-Device Identifier: 10887587017006
• UDI-Public: 10887587017006
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention