MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM; SCREW, FIXATION, BONE

Model Number	02.130.011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not implanted or explanted, device broke and was not used in procedure.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on (b)(6) 2018, during an open reduction of internal fixation (orif) of a metacarpal fracture procedure, when the surgeon doing the final tightening of the two (2) cortex screws, the heads of the screws ripped off when providing tension on the screw to suck it down to the plate.The drill bit was also broken.The part of a broken drill bit and two of the cortex screw heads were removed and while the other parts of the broken screws and drill bit were left in the patient.Fragments from broken devices were successfully removed.There was a 20-minute surgical delay.The patient outcome is unknown.Concomitant device reported: unknown plate (part, lot, & quantity is unknown).This complaint involves three (3) devices.This report is 2 of 3 for (b)(4).

• Brand Name: 1.3MM CORTEX SCREW SLF-TPNG WITH T4 STARDRIVE RECESS 11MM
• 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: 7926458
• Report Number: 2939274-2018-54058
• Device Sequence Number: 1936872
• Product Code: HWC
• UDI-Device Identifier: 10886982044174
• UDI-Public: (01)10886982044174
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K150099
• 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): 09/07/2018

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: 02.130.011
• Device Catalogue Number: 02.130.011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2018
• Initial Report FDA Received Date: 10/02/2018
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Weight: 61