MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5 VA LCKNG SCR SLF-TPNG/SD/85; PLATE, FIXATION, BONE

Model Number	02.127.185
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, after inspection of the back up instruments, these were set aside for complaints.No patient involvement.This report is for one (1) 3.5 va lckng scr slf-tpng/sd/85.This is report 8 of 8 for complaint (b)(4).
Additional Manufacturer Narrative
Additional narrative: additional product code: hwc.A device history record (dhr) review was conducted: visual inspection: the complaint item, packaging for part# 02.127.185, lot#6l20815 was returned to cq (b)(4).The outer packaging was deformed.Upon visual inspection, no item was found inside the packet and there was a small opening in the sealing of the package.The packaging was sent to the manufacturing site (b)(4) for investigation and this summary is based on the report from (b)(4) attached under the notes and attachment section.Document/specification review: based on the date of manufacture, the current and manufactured version of drawings for the part was reviewed: 3.5mm variable angle locking screw, se_300566 rev h (current and manufactured) dimensional inspection: this was not performed due to the complaint condition of missing item from the package.Conclusion: the complaint device packaging was returned empty which is due to the item falling out due to the improper sealing of the package.This was a confirmed manufacturing issue and jabil nc (b)(4) was opened.A jnj nc, (b)(4) opened to track the proceedings of the investigation.Additionally, (b)(4) was opened on (b)(6) 2020 to address issues of this kind but since this lot is from 2019, the investigation will be conducted through (b)(4).Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - a manufacturing record evaluation was performed for the finished device lot and no non-conformance was identified.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.

• Brand Name: 3.5 VA LCKNG SCR SLF-TPNG/SD/85
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13285404
• Report Number: 2939274-2022-00210
• Device Sequence Number: 20101344
• Product Code: HRS
• UDI-Device Identifier: 10886982043399
• UDI-Public: (01)10886982043399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 02.127.185
• Device Catalogue Number: 02.127.185
• Device Lot Number: 6L20815
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BENDING IRON FOR 2.7MM & 3.5MM PLATES; CANN CONNECTING SCREW FOR STD INSRT H≤ CANNULATED 2.5MM HEXAGONAL SCREWDRIVER; DEPTH GAUGE FOR 2.0/2.4 AND 2.7 SCREWS; DEPTH GAUGE FOR LCKNG SCRS TO 100; DEPTH GAUGE FOR LCKNG SCRS TO 100; EXTRACTION SCR FOR TI FEM & TIB NAIL; GD BLK 2.7/3.5 VA ANTLAT DSTL TIB PL/RT; SCRDRIVERSHAFT-HEX-LRG Ø3.5 L165 F/QC; SCREWDRIVER, HEXAGONAL, SMALL, WITH HOLDING SLEEVE; SDDRIVE SCREWDRIVER SHAFT T8 105MM; SHARP HOOK; SMALL HEXAGONAL SCREWDRIVER SHAFT; UNK - SCREWDRIVERS
• Patient Sex: Unknown