MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LCKNG SCRS TO 100; GAUGE, DEPTH

Model Number 03.010.072

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.A device history record (dhr) review was conducted: visual inspection: the complaint device depth gauge for lckng scrs to 100 (product code: 03.010.072, lot number: l832726) was returned to cq west chester for investigation.During visual inspection, the depth gauge needle was bent and deformed.Also, the slider assembly and the cover for needle were severely scratched.Document /specification review: based on the date of manufacture, the current and manufactured version of the drawings were reviewed.Locking screw measuring device for 188mm sleeve, 03_010_072, rev h (current) and rev f(manufactured) slider assembly, 03_010_072_2, rev h (current) and rev f(manufactured) hook slider assembly, 03_010_072_2_2 rev d (current and manufactured) dimensional inspection: according to 03_010_072_2_2 rev d, diameter: 1.1 mm ± 0.1 mm (specified dimension) diameter: 1.06 mm (measured dimension, conforming) conclusion: the depth gauge needle was bent at the hook and had other visual damages.A definitive root cause was not determined during investigation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot - no ncrs were generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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 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) depth gauge for lckng scrs to 100.This is report 1 of 2 for complaint (b)(4).

• Brand Name: DEPTH GAUGE FOR LCKNG SCRS TO 100
• Type of Device: GAUGE, DEPTH
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13011968
• MDR Text Key: 288180381
• Report Number: 2939274-2021-07103
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982067449
• UDI-Public: (01)10886982067449
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.010.072
• Device Catalogue Number: 03.010.072
• Device Lot Number: L832726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 3.5 VA LCKNG SCR SLF-TPNG/SD/85; 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; 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