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 Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Product code 319.01.Lot number l302038.Manufacturing site: (b)(4).Release to warehouse date: 22.June 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The depth gauge for 2.7mm & small screws (p/n: 319.01, lot #: l302038) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was missing the headpiece and knurled cap components.The tip of the needle component was observed to be slightly bent.No other issues were observed with the returned device.There was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.The customer reported that the depth gauge is missing the headpiece and cap.The repair technician reported the device is missing the knurled cap and the tip of the depth gauge.Missing parts is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The item will be forwarded to customer quality.The evaluation was confirmed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Depth gauge for 2.7 mm to 4.0 mm screws.Complaint confirmed? yes, the device received was missing components.Hence confirming the allegation.Investigation conclusion the complaint condition was confirmed for the depth gauge for 2.7 mm and small screws (p/n: 319.01, lot #: l302038).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The components are able to be disassembled and were likely misplaced during the device's handling.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 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, the depth gauge was missing the headpiece and cap.It was unknown when the issue was discovered.There was no patient or procedure involvement.This report is for one (1) depth gauge for 2.7mm & small screws.This is report 1 of 1 for (b)(4).

• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11932484
• MDR Text Key: 254375521
• Report Number: 2939274-2021-02759
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189950
• UDI-Public: 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
• Report Date: 06/02/2021

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: 319.01
• Device Catalogue Number: 319.01
• Device Lot Number: L302038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2017
• 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