MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.5MM VAL Y-PLATE 3 HOLES HD-7 HOLES SHAFT; PLATE,FIXATION,BONE

Model Number	02.130.253
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: 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.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 july 14, 2020 after the insertion of the variable angle (va) locking t-plate and unknown locking screw, the surgeon decided to change out the screw for a different length.During the re-insertion of a new unknown va locking screw, the screw head would not lock into the plate.The plate was removed and a new plate was inserted.There was no surgical delay and the procedure was successfully completed.Concomitant device: unknown screwdriver (part#: unknown, lot#: unknown, quantity 1).This report is for one (1) 1.5mm val y-plate 3 holes hd-7 holes shaft.This is report 1 of 2 for (b)(4).

• Brand Name: 1.5MM VAL Y-PLATE 3 HOLES HD-7 HOLES SHAFT
• 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: 10367875
• Report Number: 2939274-2020-03375
• Device Sequence Number: 16986935
• Product Code: HRS
• UDI-Device Identifier: 10886982044815
• UDI-Public: 10886982044815
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K141527
• 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): 07/14/2020

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: 02.130.253
• Device Catalogue Number: 02.130.253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/05/2020
• Patient Sequence Number: 1