MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LCKING ANTEROLATERAL CALCANEAL PL SHORT 40MM LEFT; PLATE, FIXATION, BONE

Model Number	02.211.411
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an unknown date, during an unknown procedure, retention pin screwdriver stripped, variable angle (va) anterolateral calcaneal locking plate hole was stripped, variable angle (va) spherical drill guide is stripped, proximal tibial plate sterile boxed plate had a stain.The trocar with handle button was stripped and the inter-lock screwdriver broke off when trying to detach the screw.There was a surgical delay of unknown minutes.Procedure outcome is unknown.There was no patient consequence.Concomitant device reported: screw (part number unknown, lot unknown, quantity 1).Scrwdrvr f/4.5mm ti multiloc screws/slf-retain/330mm (part number 03.019.025, lot unknown, quantity 1).3.5mm proximal tibia plate 6 holes/right-sterile (part number 241.006s, lot unknown, quantity 1).4.3mm va spherical drill guide long f/5.0mm va lckng screws (part number 03.231.008, lot unknown, quantity 1).Trocar with handle for use with 03.120.014 (part number 03.120.015, lot unknown, quantity 1) inter-lock screwdriver t25/3.5mm hex/224mm (part number 03.010.473, lot unknown, quantity 1).This report involves one (1) 2.7mm va-lcking anterolateral calcaneal pl short 40mm left.This is report 2 of 3 for (b)(4).

• Brand Name: 2.7MM VA-LCKING ANTEROLATERAL CALCANEAL PL SHORT 40MM LEFT
• 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: 11345021
• Report Number: 2939274-2021-00948
• Device Sequence Number: 5036600
• Product Code: HRS
• UDI-Device Identifier: 10886982055002
• UDI-Public: (01)10886982055002
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• 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): 01/29/2021

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: 02.211.411
• Device Catalogue Number: 02.211.411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/18/2021
• Patient Sequence Number: 1