MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR LARGE SCREWS; GAUGE, DEPTH

Model Number 319.10

Device Problem Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Part: 319.100-us, lot: l858698, manufacturing site: (b)(4), release to warehouse date: 28 august 2018.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Visual inspection: the depth gauge for large screws (p/n: 319.10, lot #: l858698) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the needle component of the device was bent and deformed.The device was also missing the knurled cap.No other issues were identified with the returned components of the device.Device failure/defect identified? yes.Service and repair evaluation: the customer reported that the depth gauge for large screws was missing a component.The repair technician reported the gauge is bent and missing the knurled cap.Bent 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.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Also, the defect is post-manufacturing defect so dimensional inspection is not required.Document/specification review.Based on the date of manufacture, the current and manufactured revision of drawings were reviewed depth gauge assembly (current & manufactured).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 large screws (p/n: 319.10, lot #: 4l858698).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance or incorrectly assembled during the sterilization process.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, during a routine incoming inspection of the loaner set, it was observed that the depth gauge for large screws was missing a component.There was no patient involvement.This report is for one (1) depth gauge for large screws.This is report 1 of 1 for (b)(4).

• Brand Name: DEPTH GAUGE FOR LARGE 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): SYNTHES HAEGENDORF GMBH-CN; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12533734
• MDR Text Key: 273409761
• Report Number: 2939274-2021-05771
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982190017
• UDI-Public: 10886982190017
• 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: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 319.10
• Device Catalogue Number: 319.10
• Device Lot Number: L858698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• 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