MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM UNIVERSAL DRILL GUIDE

Model Number 323.202

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

Occupation: reporter is jnj representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Service and repair evaluation: the customer reported the device was broken.The repair technician reported the device was missing a spring.Missing component is the reason for repair.The cause of the issue is not determined.The following parts were replaced: compression spring, and all applicable components.The item was repaired per the inspection sheet, passed synthes final inspection on jan 11, 2021 and will be returned to the customer upon completion of the service and repair process.Attached service record router completed through operation 30.Finalized service record will be archived in tungsten document management system.The evaluation was not confirmed.The device was deemed serviceable and will be returned to the customer, no design or manufacturing issues were identified therefore it has been determined that no corrective and/or preventative action is proposed.Device history lot part # 323.202 lot # l884707 manufacturing site: (b)(4).Release to warehouse date: aug.22, 2018 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.

Event Description

It was reported that on an unknown date, during routine incoming inspection of a loaner set at fsl ups (b)(6) site, it was observed that the universal drill guide was broken.There was no known patient or hospital involvement.This complaint involves one (1) device.This report involves one (1) 2.4mm universal drill guide.This is report 1 of 1 for (b)(4).

• Brand Name: 2.4MM UNIVERSAL DRILL GUIDE
• Type of Device: GUIDE
• 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: 11230689
• MDR Text Key: 228891387
• Report Number: 2939274-2021-00488
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 10886982190789
• UDI-Public: (01)10886982190789
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 323.202
• Device Catalogue Number: 323.202
• Device Lot Number: L884707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2018
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1