MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT; PLATE, FIXATION, BONE

Model Number	02.118.404
Medical Device Problem Codes	Device-Device Incompatibility (2919); 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.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, during an unknown procedure, the variable angle (va) locking screws did not lock into the plates used.An alternative plate was used, and the same hole was stripped.Locking compression plate (lcp) distal fibula plate was used and it worked.The depth gauge tip broke off during measurement.The large fragment plate had rust on it as well.The broken fragments were retained in the patient.The procedure was successfully completed with a three (3) minute surgical delay.No patient consequences.Concomitant devices reported: 2.7mm va-lcp lateral distal fibula plate/3 holes/right (part number 02.118.400, lot unknown, quantity 1), depth gauge for 2.0mm and 2.4mm screws (part number 319.006, lot unknown, quantity 1), 4.5mm narrow lcp® plate 11 holes/206mm (part number 224.611, lot unknown, quantity 1).This report involves one (1) 2.7mm va-lcp lateral distal fibula plate/5 holes/right.This is report 3 of 3 for (b)(4).

• Brand Name: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/5 HOLES/RIGHT
• 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: 11087924
• Report Number: 2939274-2020-05743
• Device Sequence Number: 3000382
• Product Code: HRS
• UDI-Device Identifier: 10886982038869
• UDI-Public: (01)10886982038869
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K120854
• 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: 02.118.404
• Device Catalogue Number: 02.118.404
• 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