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

Model Number	314.27
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11920636
• Report Number: 2939274-2021-02712
• Device Sequence Number: 3269091
• Product Code: HXX
• UDI-Device Identifier: 10886982188731
• UDI-Public: 10886982188731
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1