MAUDE Adverse Event Report: SYNTHES GMBH LARGE HEXAGONAL SCREWDRIVER; SCREWDRIVERS

Model Number	314.27
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date, that the wood handled instruments are leaving a stain/residue when they are peel-packed and sterilized.There were no patient consequence.This complaint involves fourteen (14) devices.This report is for one (1) large hexagonal screwdriver this is report 13 of 14 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 expected to be returned for manufacturer review/investigation but has yet to be received.E3: reporter is a j&j sales representative.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.
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.H10 additional narrative: h3, h4, h6 investigation summary: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the large hexagonal screwdriver was worn from the handle and the shaft surface.The device show traces of usage, the handle is worn, and the shaft shows small scratched due usage.No traces of foreign substance were found.The observed condition was consistent as an end of life indicator for the device.No other issues were identified.After a visual inspection per guidance provided in windchill document, it was determined that the reusable instrument device was worn from repeated use and servicing; therefore, further investigation for the reported complaint device is not required.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the large hexagonal screwdriver would have contributed to the complained issue.There is no indication that a design or manufacturing issue has caused the complaint condition.It was determined that the reusable instrument was worn from repeated use and servicing.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.Drawing/specifications reviewed? yes, reviewed device history: part: 314.27.Lot no:1829524.Release to warehouse date: 21 feb, 2008.Manufacturing site: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.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: LARGE HEXAGONAL SCREWDRIVER
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HAGENDORF; im bifang 6; hagendorf CO 4614 ; SZ 4614
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16781391
• Report Number: 8030965-2023-05033
• Device Sequence Number: 6849602
• Product Code: HXX
• UDI-Device Identifier: 10886982188731
• UDI-Public: (01)10886982188731
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup

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
• Device Lot Number: 1829524
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2008
• 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: 4.0MM HEXAGONAL SCREWDRIVER; CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; DHS/DCS COUPLING SCREW; DHS/DCS COUPLING SCREW; GOUGE W/10 L205/90; LARGE HEXAGONAL SCREWDRIVER; LARGE HEXAGONAL SCREWDRIVER LONG; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE; SCRDRIVER-HEX-SMALL W/HOLD-SLEEVE; SDDRIVE SCREWDRIVER T8; SDDRIVE SCREWDRIVER T8; STR BALL SPIKE FOR LOW PRO PELVIC SYS
• Patient Sex: Unknown