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

Catalog Number 311.430

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Reporter is a j&j employee.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.

Event Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the handle with quick coupling was put in the sterilization bag for sterilization, and during sterilization something like brown color adhered inside the sterilization bag.There was no patient involvement reported.No further information is available.This report is for one (1) handle with quick coupling, small.This is report 1 of 1 for (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.H3, h6: part: 311.430, lot: 5l24697, manufacturing site: bettlach, release to warehouse date: 19.July 2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection upon visual inspection at customer quality (cq), it is observed that there were no signs of stains and the sterilization bag was not returned.The handle w/quick-coupling is in sound condition presenting normal signs of use.Functional test: function test was performed at cq ¿ quick coupling is working and did not show any irregularities.Document/specification review not required per selected investigation flow.Summary: the complaint condition is unconfirmed.A visual inspection and function check were performed as part of this investigation.No stains were observed and the possibly contaminated bag was not returned.Thus, the reported condition cannot be confirmed.The review of the production history revealed that this handle was manufactured in july 2019 according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities noted; visual and functional check were performed per 100% after the assembly of the component parts.No manufacturing related issues were found.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: HANDLE WITH QUICK COUPLING, SMALL
• Type of Device: TAP, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10479995
• MDR Text Key: 212742477
• Report Number: 8030965-2020-06532
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819019379
• UDI-Public: (01)07611819019379
• 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: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.430
• Device Lot Number: 5L24697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1