MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 6.5MM CANNULATED SCREW FULLY THREADED 80MM; SCREW, FIXATION, BONE

Model Number	208.472
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).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) 2021, two (2) cannulated screws were put into a patient¿s ankle and were be too long.When two depth gauges were compared, it was determined that the depth gauge in question, was off at least 5mm.The screws were exchanged, and surgery successfully completed.There were no fragments generated.The surgery was delayed for five (5) minutes.Concomitant devices reported: cann screw measuring device for 6.5mm & 7.3mm cann screws (part number 319.70, lot a4df803, quantity 1); 6.5mm cannulated screw fully threaded 75mm (part number 208.471, lot unknown, quantity 1).This report involves one (1) 6.5mm cannulated screw fully threaded 80mm.This is report 3 of 3 for (b)(4).

• Brand Name: 6.5MM CANNULATED SCREW FULLY THREADED 80MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11399960
• Report Number: 2939274-2021-01126
• Device Sequence Number: 1167249
• Product Code: HWC
• UDI-Device Identifier: 10886982149732
• UDI-Public: (01)10886982149732
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021932
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2021

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: 208.472
• Device Catalogue Number: 208.472
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6.5MM CANNULATED SCREW FULLY THREADED 75MM; CANN SCREW MEASURING DEVICE
• Patient Age: 36 YR
• Patient Weight: 69