MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS/50MM; SCREW, FIXATION, BONE

Model Number	202.967
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: device was used for treatment, not diagnosis.Patient weight is not available for reporting.Devices are not considered explanted or implanted.Devices are not expected to return for 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.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 during a procedure for orif (open reduction internal fixation) of distal tibia on (b)(6) 2018, two of the 2.7mm cortex screw slf-tpng with t8 stardrive recess/50mm got bent when the surgeon was trying to implant them.One screw was left inside the patient and the other screw was explanted.The procedure was successfully completed with no surgical delay.The patient was stable after the surgery.Concomitant devices reported: unk - plates: trauma (part # unknown, lot # unknown, qty # 1).(b)(4).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS/50MM
• 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: 7345085
• Report Number: 2939274-2018-51093
• Device Sequence Number: 84264
• Product Code: HWC
• UDI-Device Identifier: 10886982145246
• UDI-Public: (01)10886982145246(10)UNKNOWNLOTNUMBER
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 02/19/2018

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: 202.967
• Device Catalogue Number: 202.967
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2018
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR