MAUDE Adverse Event Report: SYNTHES GMBH SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS

Catalog Number	314.070
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from depuy synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery.Before surgery, when the products were prepared and checked after sterilization, the adhesion of viscous liquid on the surface of the handle was confirmed.The surgery was completed successfully with no surgical delay.No further information is available.This report is for one (1) small hexagonal screwdriver 2.5mm width across flats.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: device history record (dhr) review conducted: part # 314.070 lot # 1712530 manufacturing site: werk hagendorf.Release to warehouse date: 19 july 2007.Supplier: n/a.Expiration date: n/a.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation did not reveal any evidence to confirm any foreign substance condition on the device 314.070, scrdriver-hex-small 2.5 w/groove.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not required.The overall complaint was unconfirmed as the observed condition of the device 314.070, scrdriver-hex-small 2.5 w/groove would contribute 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 complaint condition.As part of depuy synthes 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.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: SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES HAEGENDORF GMBH; im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17366563
• Report Number: 8030965-2023-09050
• Device Sequence Number: 6617789
• Product Code: HXX
• UDI-Device Identifier: 07611819019829
• UDI-Public: (01)07611819019829
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,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: 314.070
• Device Lot Number: 1712530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2007
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE W/QUICK-COUPL
• Patient Sex: Unknown