MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4.5MM BROAD LCP PLATE 7 HOLES/134MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	226.571
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes hwc, and hrs.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) 2020, the variable angle locking compression plate holes were stripped, a variable angle cone was used in the va distal fibula plates, and a locking drill tower in the large fragment plate.There was a five (5) minute surgical delay.The procedure successfully completed.No patient consequence.Concomitant devices reported: 2.7mm va-lcp lateral distal fibula plate/3 holes/left (part number 02.118.401, lot unknown, quantity 1), 2.7mm va-lcp lateral distal fibula plate/5 holes/left (part number 02.118.405, lot unknown, quantity 1).This report involves one (1) 4.5mm broad lcp® plate 7 holes/134mm.This is report 1 of 3 for (b)(4).

• Brand Name: 4.5MM BROAD LCP PLATE 7 HOLES/134MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11088309
• Report Number: 2939274-2020-05747
• Device Sequence Number: 19515817
• Product Code: KTT
• UDI-Device Identifier: 10886982159052
• UDI-Public: (01)10886982159052
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082807
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2020

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: 226.571
• Device Catalogue Number: 226.571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 12/29/2020
• Patient Sequence Number: 1