MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T; GAUGE, DEPTH

Catalog Number 319.006

Device Problem Break (1069)

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

Event Date 01/05/2022

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.A device history record (dhr) review was conducted: visual inspection: the depth gauge f/scr ø2+2.4 meas-range up-t was received for analysis.Upon visual inspection, it was observed the needle component of the device had broken off and included in package, confirming the complaint condition.Protection sleeve is missing.Dimensional inspection: a dimensional inspection was not performed due to the post manufacturing damage of the device.Investigation conclusion: this complaint is confirmed as the needle component of the complaint device had broken off.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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 ncr's 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 on (b)(6) 2022, during a procedure the depth gauge was broke while surgeon was using it.The metallic hook detached from the portion of the depth gauge with the measurements on it and another depth gauge was used.Procedure was completed successfully with no fragments generated.This report is for one (1) depth gauge f/scr ø2+2.4 meas-range up-t.This is report 1 of 1 for complaint (b)(4).

• Brand Name: DEPTH GAUGE F/SCR Ø2+2.4 MEAS-RANGE UP-T
• 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: 13424260
• MDR Text Key: 290466742
• Report Number: 2939274-2022-00329
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 07611819707238
• UDI-Public: (01)07611819707238
• 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: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 319.006
• Device Lot Number: 7058669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1