MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SLIDE/FIXED HAMMER 700 GRAMS; HAMMER,SURGICAL

Catalog Number	03.010.056
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
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, the patient underwent an open reduction internal fixation (orif) surgery for right tibia diaphysis fractures using the expert tibial nail system.Before the surgery the hospital found that the case had been tainted in a brown color.Later, they found that the disposable sheet to wrap this case had also been tainted in a brown color.They did not find any breakage that would lead to a problem.They wiped down the case and then used the instruments.The surgery was successfully completed.This report is for one (1) slide/fixed hammer 700 grams.This is report 3 of 3 for (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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.Visual inspection: upon visual inspection of the complaint device it can be seen that the returned hammer is used (sings of scratches and dents), but still in a good condition and fully functional.Since the product was delivered decontaminated/sterilized status, the bleeding out of the handles could not be reproduced anymore.Document/specification review: the manufacturing review shows that the production procedures were according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.Summary: the review of the production history revealed that this item was manufactured in february 2012 according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.The received condition of the device is concordant with the complaint description and the complaint condition is confirmed.The root cause (regarding the bleeding out handles) was identified during the performed cq evaluation and therefore the in the investigation flow listed remaining investigation steps are not required.The potential cause for this investigation will be rated as normal wear, since the product was in use for 8 years.We wish to assure you that the canevasit/phenolic handles, although they are no longer the state of the art choice, are safe to use.Tests carried out by an independent laboratory (medical device services, d-82205 gilching) have confirmed that a new canevasit handle, after sterilization is not cytotoxic.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.Synthes recommends following the available reprocessing instructions to avoid possible problems (see information sheet or refer to https://emea.Depuysynthes.Com/hcp/reprocessing-care-maintenance.) based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history part: 03.010.056, lot: 7764806, manufacturing site: hägendorf, release to warehouse date: 21.February 2012.A manufacturing record evaluation was performed for the finished device lot number, 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: SLIDE/FIXED HAMMER 700 GRAMS
• Common Device Name: HAMMER,SURGICAL
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10144583
• Report Number: 8030965-2020-04111
• Device Sequence Number: 2561288
• Product Code: FZY
• UDI-Device Identifier: 07611819760868
• UDI-Public: 07611819760868
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2020

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: 03.010.056
• Device Lot Number: 7764806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2020
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 06/12/2020; 07/08/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/26/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1