MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 95 DEG DCS® PLATE 8 HOLES 146MM-STERILE; APPLIANCE,FIXATION,NAIL

Model Number	281.980S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.(b)(4).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.(b)(4).
Event or Problem Description
This report is against user facility medwatch number (b)(4).The only information contained in this report is correction or additional information.Concomitant device: unknown screws (part # unknown, lot # unknown, quantity 8).This report is for one 95 deg dcs® plate 8 holes 146mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 95 DEG DCS® PLATE 8 HOLES 146MM-STERILE
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9823391
• Report Number: 2939274-2020-01238
• Device Sequence Number: 16911237
• Product Code: KTT
• UDI-Device Identifier: 10886982178138
• UDI-Public: (01)10886982178138
• Combination Product (Y/N): N
• PMA/510(K) Number: K791619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/14/2020

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: 281.980S
• Device Catalogue Number: 281.980S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention