MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.7MM & SMALL SCREWS; GAUGE, DEPTH

Model Number 319.01

Device Problem Incorrect Measurement (1383)

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

Event Date 11/17/2021

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2021, during an ankle reconstruction procedure, the hook on the end of the depth gauge wasn't grabbing the bone.A different depth gauge was used.There was no surgical delay.The procedure was successfully completed.Patient outcome is unknown.During manufacturer's investigation of the returned device it was noted that the tip of the depth gauge is bent.This report is for one (1) depth gauge for 2.7mm & small screws this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Additional narrative: reporter is a j&j sales representative.A product investigation was conducted.Visual inspection: the complaint device, depth gauge for 2.7mm & small screws (product code: 319.01, lot number: 9872605) was returned to cq west chester for investigation.Upon visual inspection, the tip of the depth gauge was found bent.Service and repair evaluation: the customer reported the hook on the end of the depth gauge wasn't grabbing the bone.The depth gauge tip was reported bent by the repair technician.The cause of the issue was not determined.The reason for repair is bent.The item is being scrapped as it could not be repaired per the inspection sheet and will be forwarded to customer quality.The evaluation was confirmed.Document/specification review: based on the date of manufacture, the current and manufactured version of drawings were reviewed.Dimensional inspection: this is identified to be a post manufacturing damage, hence a dimensional inspection was not performed.Investigation conclusion: the depth gauge tip was found bent.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.A device history record (dhr) review was conducted: part #: 319.010-us.Lot #: 9872605.Manufacturing site: (b)(4).Release to warehouse date: 09 aug 2016.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were 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: DEPTH GAUGE FOR 2.7MM & SMALL 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): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13261470
• MDR Text Key: 287252472
• Report Number: 2939274-2022-00186
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: (01)10886982189950
• 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: 01/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.01
• Device Catalogue Number: 319.01
• Device Lot Number: 9872605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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