MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 10MM; PLATE, FIXATION, BONE

Model Number	201.360.97
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.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 unknown date, the patient underwent a surgery for removal of hardware.During the surgery, it was noted that various small screws broke off on va distal humerus plates.These screws were too difficult to remove and have been left in patient bone.It is unknown if the surgery was successfully completed.It is unknown if there was a fragment generated.Patient status is unknown.Concomitant devices reported: unk - plates: lateral va-lcp proximal tibia plate(part# unknown, lot# unknown, qty unknown).This complaint involves five (5) devices.This report is for (1) 2.0mm cortex screw slf-tpng with stardrive recess 10mm.This report is 3 of 5 for (b)(4).

• Brand Name: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 10MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12349127
• Report Number: 2939274-2021-04772
• Device Sequence Number: 4067434
• Product Code: HRS
• UDI-Device Identifier: 10886982141859
• UDI-Public: (01)10886982141859
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 07/23/2021

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: 201.360.97
• Device Catalogue Number: 201.360.97
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/21/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.0 CORTEX SCREW SLF-TPNG SD RECESS 10.; 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 10.; 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 10.; 2.7MM VA LCK SCREW SLF-TAP.; 2.7MM VA LCK SCREW SLF-TAP.; UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE.; UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE.; 2.7 CORTEX SCREW SLF-TPNG T8 SD REC 10; 2.7MM VA LCK SCREW SLF-TAP; UNK - PLATES: LATERAL VA-LCP PROXIMAL TIBIA PLATE
• Patient Age: 25 YR