MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM HEXAGONAL SCREWDRIVER

Catalog Number	313.93
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was pitting on device.No operation was involved.No patient was involved.
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: investigation summary the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the shaft was covered with an unknown foreign substance.The allegation of corrosion is not being confirmed as the observed foreign substance is of unknown origin.No other problems observed.The potential cause is attributed to cleaning/sterilization methods.As per procedure, all devices must be thoroughly cleaned and inspected prior to sterilization.During cleaning, only use cleaning agents that are labelled for use on medical devices and in accordance with the manufacturer¿s instructions (e.G.Temperature, contact time, and rinse time).Cleaning agents with a used dilution ph of within 7¿9.5 are recommended.Highly alkaline conditions (ph >11) can damage components/devices, such as aluminum materials.Do not use saline, environmental disinfection (including chlorine solutions) or surgical antiseptics (such as iodine- or chlorhexidine-containing products).Do not use a cleaning aid that can damage the surface of instruments such as steel wool, abrasive cleaners or wire brushes.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 4.0mm hexagonal screwdriver would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a device history part # 313.93 synthes lot # 5220675 supplier lot # 5220675 release to warehouse date: 18 apr 2006 manufactured by- synthes brandywine.No 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.0MM HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22012503
• Report Number: 8030965-2025-04782
• Device Sequence Number: 5343168
• Product Code: HXX
• UDI-Device Identifier: 10886982188243
• UDI-Public: (01)10886982188243(10)5220675
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 313.93
• Device Lot Number: 5220675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown