MAUDE Adverse Event Report: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM; SCREW, FIXATION, BONE

Model Number	202.876
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, during an open reduction internal fixation (orif) right lateral malleolus procedure of an ankle, the screw head sheared off the shaft of the screw as the surgeon was tightening it manually.The surgeon applied a 5h 2.7mm va-lcp lateral distal fibula locking plate to the patient using two (2) 1.6mm k-wires to temporarily hold the plate in place.Then drilled the 2nd most proximal 2.7mm cortex screw hole using a 2.0 drill bit.The surgeon then measured for the screw and began implanting a 16mm x 2.7mm (202.876) t8 stardrive recess cortex screw.The screws were implanted using power, then finally tightened screw with a manual screwdriver.As he was tightening manually, the screw head sheared off the shaft of the screw.A broken hardware removal set was asked.Fragments were generated but were not removed.It was decided to leave the shaft of the screw in the fibula rather than trephining it put and causing more trauma to the bone.There were a 2 minutes surgical delay.The procedure was successfully completed.There were no patient consequences.This report is for one (1) 2.7mm cortex screw slf-tpng with t8 stardrive recess 16mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM
• Common Device Name: SCREW, FIXATION, BONE
• MDR Report Key: 12747943
• Report Number: 2939274-2021-06478
• Device Sequence Number: 19953386
• Product Code: HWC
• UDI-Device Identifier: 10886982145079
• UDI-Public: (01)10886982145079
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 10/08/2021

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: 202.876
• Device Catalogue Number: 202.876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention