MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS; SCREWDRIVERS

Catalog Number	314.070
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during an unknown procedure on an unknown date one (1) 2.5mm hexagonal screwdriver with groove was found to have spots on the pack and were only noticed in the opening of the kit when the patient was in the anesthetized room.The surgeon did not use j&j material and requested competitor material.According to the customer, the use of celeron cable instruments was no longer allowed by anvisa due to the possibility of impregnation of the devices during cleaning.The customer complains that after sterilization, these instruments have stained the packaging the used to protect the cable during sterilization and reported that the cable materials was porous.The procedure was successfully completed with a surgical delay.Patient outcome was unknown.This report is for one (1) small hexagonal screwdriver.This is report 1 of 1 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.A device history record (dhr) review was conducted: part: 314.070.Lot: 3029771.Manufacturing site: haegendorf.Release to warehouse date: 11.Nov.2008.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.Visual inspection: visual inspection performed at customer quality (cq) of the complaint device confirmed the condition of foreign substance next to the device.The photos show a brown substance on the paper next to the phenolic handle instrument.The actual device was returned to cq, however no foreign substance was observed on the device.It is possible that the sterilization/decontamination process at monument has removed any evidence of the brown substance.The received image condition does agree with the complaint description.Complaint cannot definitively confirm that the stain originated from the complaint device as the returned device is not leaching any brown residue.Synthes recommends to follow the available reprocessing instructions to avoid possible problems as part of our aspiration to offer the best quality products to our clients, in 2013, synthes initiated a program to replace the canevasit/phenolic handles of all instruments sold with either medical grade silicone rubber or polyphenylsulfone (ppsu).We have identified over 300 different instruments with canevasit/phenolic handles.Many of the most sold articles are already available in either silicone or ppsu.We at depuy synthes like to assure you that we are committed to offer all instruments with either silicone or ppsu handles by end 2021 and like to thank you for your cooperation and patience.A dimensional inspection is not relevant for this complaint condition.Investigation conclusion: a definitive assignable root cause for the reported condition could not be determined based on the provided information.This complaint is confirmed for photo showing staining but not confirmed for the stains originating from the complaint device or how the stains occurred.No product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.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.

• Brand Name: SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS
• Common Device Name: SCREWDRIVERS
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8505472
• Report Number: 8030965-2019-62710
• Device Sequence Number: 11098198
• Product Code: HXX
• UDI-Device Identifier: 07611819019829
• UDI-Public: (01)07611819019829
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2019

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: 3029771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 04/11/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1