MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT

Model Number	03.111.600
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
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.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, some of the 2.4mm cortex screws were not fitting through the plate guides for the two column variable angle distal radius plates.The set was opened and tested the three (3) 2.4mm cortex screws 20mm, two (2) 2.4mm cortex 22mm, and one (1) 2.4mm cortex 24mm.The 2.4mm cortex screws would not fit through the guide block for two-column plate 6 hole head, guide block for two-column plate 7 hole head, nor the guide block for two-column plate narrow 6 hole.The rest of the 2.4mm cortex screws did.The issue was found in sterile processing department (spd).There was no patient involvement.Concomitant devices reported: unknown cortex screws (part# unknown, lot# unknown, quantity# unknown).This complaint involves nine (9) devices.This is 1 of 9 for report (b)(4).

• Brand Name: GUIDE BLOCK FOR 2 COLUMN PLATE 6 HOLE HEAD/RIGHT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9244328
• Report Number: 2939274-2019-61772
• Device Sequence Number: 2550215
• Product Code: FZX
• UDI-Device Identifier: 10886982072467
• UDI-Public: (01)10886982072467
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.111.600
• Device Catalogue Number: 03.111.600
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1