MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL; PLATE, FIXATION, BONE

Model Number	440.834
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information is unknown.It is unknown when the screw became cold-welded to the plate.Additional procode: ktt.Lot number is unknown.Date of implantation is unknown.Date of explantation is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter facility, address, and phone number are unknown.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.(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
(b)(6) reports that during removal of tomofix lateral distal femur plate on an unknown date, the surgeon described the screw and plate junction status as ¿cold welding¿.The surgeon had trouble removing the titanium tomofix plate because the unknown screws strongly adhered to the plate.The surgeon always finished the last screw insertion threads using a torque limiting screwdriver as describe and proposed in the technique guide.During the removal, the surgeon had to use a broken screw removal set and diamond burr to shear off the screw head at the plate junction to enable removal of the plate and screw construct.The surgeon added that the plate always achieved clinical result goal but the construct is a nightmare to remove after bone healing.It was unknown if there was a surgical delay related to the event.There was no patient consequence reported.This report is for a ti tomofix(tm) medial high tibia plate-4 holes.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Corrected data: brand name, catalog, udi, physical manufacture site.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.

• Brand Name: TI TOMOFIX MEDIAL HIGH TIBIA PLATE-4 HOLES/SMALL
• 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: 7669697
• Report Number: 2939274-2018-52737
• Device Sequence Number: 2770799
• Product Code: HRS
• UDI-Device Identifier: 10886982220691
• UDI-Public: (01)10886982220691
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K141796
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 440.834
• Device Catalogue Number: 440.831
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2018
• Supplement Date Received by Manufacturer: 08/10/2018
• Initial Report FDA Received Date: 07/09/2018
• Supplement Report FDA Received Date: 08/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention