MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 3.5MM CORTEX SCREWS; GAUGE, DEPTH

Catalog Number 319.091

Device Problem Mechanical Problem (1384)

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

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the depth gauge f/cortscr ¿3.5 meas-range up (p/n: 319.091, lot #: ft00143) was returned and received at us cq.Upon visual inspection, it was observed that the slider component was received disassembled from the body and the hook component was bent and deformed.There were scratches on the device but have no impact on the device functionality.No other issues were identified with the returned device.Functional test: a functional test was performed on the returned components of the device.The slider assembly failed to assemble with the body of the depth gauge due to the bent hook.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Depth gauge for 3.5 mm pelvic screws.Slider asm, depth gauge for 3.5 mm pelvic screws.Investigation conclusion: the complaint condition was confirmed for the depth gauge f/cortscr ¿3.5 meas-range up (p/n: 319.091, lot #: ft00143).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the hook of the device.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.A device history record (dhr) review was conducted: manufacturing location: supplier: (b)(4).Release to warehouse date: 16-sep-2016.Part number: 319.091, depth gage for 3.5mm cortex screws.Lot number: ft00143 (non-sterile).Lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Certificate of compliance supplied to (b)(4) dated 18-aug-2016 was reviewed and determined to be conforming.Certificate indicates that this lot was accepted (via source inspection) by (b)(4) on 01-sep-2016.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev f was reviewed and determined to be conforming.Note: only the sample quantity of (b)(4) required repackaging and relabeling.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the depth gauge is defective.No patient consequences reported.No further information provided.During manufacturer's investigation of the returned device it was observed that the slider component was received disassembled from the body and the hook component was bent and deformed.There were scratches on the device but have no impact on the device functionality.This device condition was evaluated and determined to be reportable on (b)(6) 2020.This report is for 1 depth gauge for 3.5mm cortex screws.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 10938803
• MDR Text Key: 219340601
• Report Number: 2939274-2020-05430
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819796928
• UDI-Public: (01)07611819796928
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.091
• Device Lot Number: FT00143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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