MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.0MM SETSCREW EXTRACTOR-LONG; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	03.611.033
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant device is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.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, patient underwent a screw removal procedure for unknown reason.Broke an easy out trying to remove an ortho-pediatrics 7mm screw.A broken piece retained inside screw.Fragments were generated and were retained.There was no surgical delay.There was no patient consequence.This complaint involves one (1) device.This report is 1 of 1 for (b)(4).

• Brand Name: 3.0MM SETSCREW EXTRACTOR-LONG
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11685741
• Report Number: 2939274-2021-01917
• Device Sequence Number: 3014961
• Product Code: LXH
• UDI-Device Identifier: 10705034713861
• UDI-Public: (01)10705034713861
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: 03.611.033
• Device Catalogue Number: 03.611.033
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1