MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM RIGHT; PLATE, FIXATION, BONE

Model Number	02.211.402
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier mrn: (b)(4).Additional device product codes: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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, while repairing a calcaneus the surgeon was inserting a locking 2.7 screw percutaneously through a small incision in the skin.After inserting the screw, the surgeon realized he had missed the va calcaneus plate and buried the screw in the bone.The surgeon elected to not retrieve the screw buried in the bone.In another portion of this case, the surgeon used a variable angle locking hole multiple times and resulted in the screw locking mechanism no longer working.The surgeon ended up removing the screw.There was no surgical delay reported.The procedure was successfully completed.There was no patient consequence.Concomitant devices reported: screwdriver (part number unknown, lot unknown, quantity 1), screws: locking (part number unknown, lot unknown, quantity 2).This report involves 1 2.7mm va-locking calcaneal plate medium 64mm right.This is report 3 of 3 for (b)(4).

• Brand Name: 2.7MM VA-LOCKING CALCANEAL PLATE MEDIUM 64MM 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: 10566033
• Report Number: 2939274-2020-04235
• Device Sequence Number: 19487418
• Product Code: HRS
• UDI-Device Identifier: 10886982054821
• UDI-Public: (01)10886982054821
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: 02.211.402
• Device Catalogue Number: 02.211.402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWDRIVERS; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Weight: 57