MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 1.3MM AND 1.5MM SCREWS; GAUGE, DEPTH

Model Number 319.004

Device Problem Use of Device Problem (1670)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that during a routine incoming inspection of a loaner set at a field stocking location on an unknown date, it was observed that the depth gauge for 1.3mm and 1.5mm screws was missing a component.There is no known patient or hospital involvement.Upon manufacturer investigation, it was determined that the device's needle was bent.This report is for a depth gauge for 1.3mm and 1.5mm screws.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional narrative: initial reporter is a synthes employee.Device part 319.004, synthes lot 6187329, supplier lot n/a, release to warehouse date: july 24, 2009, manufactured by synthes (b)(4).No nonconformance reports (ncrs) were generated during production.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.Visual inspection: the complaint device depth gauge for 1.3mm and 1.5mm screws was returned to customer quality (cq) west chester for investigation.The protection sleeve for the depth gauge was missing and the needle appeared bent.Document/specification review: based on the date of manufacture, the current and manufactured revisions of the part were reviewed.Depth gauge for 1.3/1.5mm screws.Dimensional inspection: it is evident that a component was missing from the gauge, hence a dimensional inspection was not performed.Complaint confirmed: the complaint condition of missing component can be confirmed during physical device investigation.Conclusion: the sleeve was missing and the needle of the depth gauge appeared bent during investigation.A definitive assignable root cause cannot be identified from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.

• Brand Name: DEPTH GAUGE FOR 1.3MM AND 1.5MM 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): BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12968236
• MDR Text Key: 287205441
• Report Number: 2939274-2021-07010
• Device Sequence Number: 1
• Product Code: HTJ
• UDI-Device Identifier: 10886982189936
• UDI-Public: (01)10886982189936
• 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: 10/11/2021

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: 319.004
• Device Catalogue Number: 319.004
• Device Lot Number: 6187329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2009
• 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