MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH

Model Number 319.006

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Reporter is a j&j sales representative.Investigation summary investigation flow: damage/ visual.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h873106, qty# 1) was received at us cq.Upon visual inspection at cq.It is observed that the protection sleeve component was missing from the assembly.It is also observed that the needle component of the device was bent.Rest of the surface of the device shows normal wear consistent with the device use which would not contribute to the complaint condition.Thus, the complaint is being confirmed.The device failure/ defect was confirmed.Documentation/ specification review: no design issues or discrepancies were found during this investigation.The complaint was confirmed.Investigation conclusion: the complaint is being confirmed for depth gauge for 2.0mm and 2.4mm screws (part# 319.006, lot# h873106) as it is observed that the needle component was bent.No definitive root cause could be determined based on the provided information.Protection sleeve might have got misplaced during sterilization.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.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: part # 319.006, synthes lot # h873106, supplier lot # h873106, release to warehouse date: nov 06, 2020, supplier: (b)(4).No ncr's were generated during production.Device history 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 an unknown date, during a routine incoming inspection of a loaner set at fsl ups (b)(6) site, it was observed that the depth gauge, lot number h873106, was missing a piece.There was no known patient or hospital involvement.This complaint involves one (1) device.This report is for (1) unk ¿ plates.This report is 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR 2.0MM AND 2.4MM 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: 12024918
• MDR Text Key: 267927360
• Report Number: 2939274-2021-03047
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189943
• UDI-Public: 10886982189943
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/25/2021

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
• Device Operator: Health Professional
• Device Model Number: 319.006
• Device Catalogue Number: 319.006
• Device Lot Number: H873106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/18/2021
• Date Device Manufactured: 11/06/2020
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1