MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM; SCREW,FIXATION,BONE

Model Number	201.764
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hrs complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 for a surgical procedure for distal radius.The 2.4 cortex screws in the va distal radius set don't fit through the distal drill guides.The screw instead locks the guide down to the bone.Tried to use distal drill guide blocks and the screw wouldn't fit through block and locked the plate to the radius.The procedure was completed successfully without surgical delay.There was no patient consequence reported.Concomitant device reported: unk - plates: va-lcp distal radius (part# unknown; lot# unknown; quantity: 1).This complaint involves (26) devices.This report is for (1) 2.4mm cortex screw slf-tpng with t8 stardrive recess 14mm.This report is 5 of 6 for (b)(4).Related product complaint: (b)(4).

• Brand Name: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM
• 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: 12556313
• Report Number: 2939274-2021-05834
• Device Sequence Number: 19063577
• Product Code: HWC
• UDI-Device Identifier: 10886982142757
• UDI-Public: (01)10886982142757
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• 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): 09/01/2021

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: 201.764
• Device Catalogue Number: 201.764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/30/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14; 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14; 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14; 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14; 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 14