MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5 TI MATRIXRIB STR PL 30 H/300 LNTH; PLATE,FIXATION,BONE

Model Number	04.501.097
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review /investigation.Occupation: reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 an unknown date, the plate broke in patient postoperatively.The patient reports pain and hearing a clicking of plate ends rubbing.The patient has not decided to remove the broken plate.Concomitant device reported: unk - screws: matrixrib (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) 1.5 ti matrixrib str pl 30 h/300 lnth.This report is 1 of 1 for (b)(4).

• Brand Name: 1.5 TI MATRIXRIB STR PL 30 H/300 LNTH
• 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: 12321153
• Report Number: 2939274-2021-04672
• Device Sequence Number: 17218818
• Product Code: HRS
• UDI-Device Identifier: 10887587066981
• UDI-Public: (01)10887587066981
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 04.501.097
• Device Catalogue Number: 04.501.097
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention