MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LARGE HANDLE WITH QUICK COUPLING; TAP,BONE

Catalog Number 311.431

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: reporter is jnj representative.Investigation summary: investigation selection: investigation site: zuchwil selected flow: visual - foreign substance/debris/cleaning/sterilization.Visual inspection: the returned handle is in a used, 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.However, the received bags show some brown liquid spots, therefore the complaint condition will be rated as confirmed.Drawing/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 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 13 years.Synthes recommends to follow the available reprocessing instructions to avoid possible problems (see information sheet or refer to https://emea.Depuysynthes.Com/hcp/reprocessing-care-maintenance.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) 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.See attached file titled 2019-03 letter silicon handle.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history lot part number: 311.431 lot number: 2237147 manufacturing site: bettlach release to warehouse date: december 05, 2006.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.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on an unknown date that during sterilization a brown-colored liquid was leaked from the handle before the surgery.There was no surgery or patient involved.This complaint involves two (2) devices.This report is for (1) large handle with quick coupling.This is report 1 of 2 (b)(4).

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.H4, h6: part: 311.431, lot: 2141229, manufacturing site: bettlach, release to warehouse date: june 27, 2005.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the returned handle is in a used, but still good condition and fully functional.Since the product was delivered decontaminated/sterilized status, the bleeding out of the handles could not be reproduced anymore.However, the received bags show some brown liquid spots, therefore the complaint condition will be rated as confirmed.Drawing/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 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 15 years.Synthes recommends to follow the available reprocessing instructions to avoid possible problems.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 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.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.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 HANDLE WITH QUICK COUPLING
• Type of Device: TAP,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10535927
• MDR Text Key: 207022272
• Report Number: 8030965-2020-06979
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819259836
• UDI-Public: (01)07611819259836
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.431
• Device Lot Number: 2141229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1