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 Type  malfunction  

Manufacturer Narrative

Reporter is a synthes employee.Part: 319.004 synthes lot: 7723908 supplier lot: n/a release to warehouse date: june 26, 2014 expiration date: n/a manufactured by synthes jennersville no nonconformance reports (ncrs) were generated during production.Review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.Visual inspection: the depth gauge for 1.3mm and 1.5mm screws was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the device was missing a protection sleeve and the needle component was bent.No other issues were observed with the returned device.Dimensional inspection: there was conclusive evidence that the returned device was missing components, so the dimensional inspection was not performed.Document/specification review based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Depth gauge for 1.3/1.5mm screws investigation conclusion the complaint condition was confirmed for the depth gauge for 1.3mm and 1.5mm screws.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 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 during routine incoming inspection of a loaner set on an unknown date, it was observed that the depth gauge for 1.3mm and 1.5mm screws was missing a piece.There was no known patient or hospital involvement.Upon manufacturer investigation, it was determined that the needle component of the device 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).

• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11232705
• MDR Text Key: 228886796
• Report Number: 2939274-2021-00496
• 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: 12/08/2020

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: 319.004
• Device Catalogue Number: 319.004
• Device Lot Number: 7723908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2014
• 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