MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 26MM; SCREW, FIXATION, BONE

Model Number	204.826
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter is synthes sales representative.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 open reduction internal fixation (orif) when the surgeon was fixing a tibia and was drilling for a 3.5 cortex screw, the drill bit broke off and a portion remained in the patient's bone.The surgeon then put the cortex screw in and tried to remove the cortex screw and had difficulties backing it out using an unknown screwdriver, so the surgeon drilled over the opposite end of the cortex screw and a portion of it broke.There were fragments but the screw fragments were removed and all of it came out.There was a surgical delay of five to ten (5-10) minutes.The patient outcome was unknown.Concomitant device reported: unknown screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) 3.5mm cortex screw self-tapping 26mm.This is report 1 of 2 for (b)(4).

• Brand Name: 3.5MM CORTEX SCREW SELF-TAPPING 26MM
• 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: 10686387
• Report Number: 2939274-2020-04691
• Device Sequence Number: 3161593
• Product Code: HWC
• UDI-Device Identifier: 10886982146311
• UDI-Public: (01)10886982146311
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 204.826
• Device Catalogue Number: 204.826
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 10/15/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5MM DRILL BIT/QC/GOLD/110MM; UNK - SCREWDRIVERS
• Outcome Attributed to Adverse Event: Required Intervention