MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LARGE HEXAGONAL SCREWDRIVER

Model Number 314.27

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Lot number is unknown, and therefore, dhr could not be completed.If the lot number can be confirmed, the dhr will be revisited.Visual inspection: large hexagonal screwdriver (p/n: 314.27, lot #:unk) was returned and received at us customer quality (cq).Upon visual inspection, a stain was observed on the handle of the screwdriver.There were scratches on the device but have no impact on the device functionality.No other issues were observed with the returned device.Document/specification review since the exact manufactured date of the device was not identified, the current revision of drawings were reviewed: screwdriver hexagonal.Dimensional inspection: dimensional inspection was not performed as there was no evidence of damage.Complaint confirmed? yes, foreign substance was observed on the handle of the device.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the large hexagonal screwdriver (p/n: 314.27, lot #:unk).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 on (b)(6) 2021 the large hexagonal screwdriver had a rust stain.This was discovered during equipment assembly in the sterile processing department.There was no patient involvement.This report is for one (1) large hexagonal screwdriver.This is report 1 of 1 for (b)(4).

• Brand Name: LARGE HEXAGONAL SCREWDRIVER
• Type of Device: SCREWDRIVER
• 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: 11920636
• MDR Text Key: 253744729
• Report Number: 2939274-2021-02712
• Device Sequence Number: 1
• Product Code: HXX
• UDI-Device Identifier: 10886982188731
• UDI-Public: 10886982188731
• 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: 05/13/2021

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: 314.27
• Device Catalogue Number: 314.27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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