MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT

Model Number	03.111.501
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/04/2019
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.Reporter is a synthes employee.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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on (b)(6) 2019, during on a distal radius surgery, the surgeon attempted to insert a one (1) cortex screw self-tapping with stardrive recess through a one (1) guide block for two-column plate on, a one (1) variable angle (va) narrow two-column volar distal radius plate.The cortex screw would not fit through the guide block and proceeded to test out two (2) additional cortex screw on the back table through a separate guide block and was unsuccessful, a va locking screw was used instead.There was no surgical delay.The procedure successfully completed.No patient consequence.Concomitant device reported: variable angle (va) narrow two-column volar distal radius plate (part #: 02.111.531, lot #: unknown, quantity #: 1).This complaint involves three (3) devices.This is report 5 of 5 for (b)(4).

• Brand Name: GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/LT
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9240788
• Report Number: 2939274-2019-61763
• Device Sequence Number: 1892108
• Product Code: FZX
• UDI-Device Identifier: 10886982072436
• UDI-Public: (01)10886982072436
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2019

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: 03.111.501
• Device Catalogue Number: 03.111.501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/25/2019
• 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