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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH BLADE HOLDER-LEFT; RETRACTOR

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OBERDORF SYNTHES PRODUKTIONS GMBH BLADE HOLDER-LEFT; RETRACTOR Back to Search Results
Catalog Number 03.816.002
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Reporter is a sales representative.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 during the demo on an unknown date, the blade holder was not engaging with the blade and sales rep was unable to actually put together the retractor.There was no patient involvement reported.This report is for one (1) blade holder-left.This is report 1 of 3 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Visual inspection: the device received in hagendorf site "blade holder le f/03.816.001 " 03.816.002 with lot number 8120151 is in used conditions.Some scratches or signs of heavy use or damage are present on the device.Functional test: functional tests were performed on the device ("blade holder le f/03.816.001" 03.816.002 with lot number 8120151) according to inspection sheet.The following functional tests were performed: functional test: assembly/disassembly using zl function gauges.Functional test: compatibility using zl function gauges.Since the device analyzed passed all the test performed, the complaint could not be replicated.The blade holder is engaging with the blade and the retractor can be put together.Summary: the complaint is rated as unconfirmed since the device is functional as required.In hindsight, and with the provided information, it is not possible to determine the exact cause of the complained issue.We only can assume that during the operation an application error may have taken place.No manufacturing related issues could be detected.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.The root cause was identified during the performed evaluation and therefore the in the investigation flows listed remaining investigation steps are not required.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.For the detailed investigation and pictures please see in the attachment.Device history: part: 03.816.002.Lot: 8120151.Manufacturing site: (b)(4) release to warehouse date: (b)(4) 2013.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.
 
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Brand Name
BLADE HOLDER-LEFT
Type of Device
RETRACTOR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10480283
MDR Text Key208806036
Report Number8030965-2020-06535
Device Sequence Number1
Product Code GAD
UDI-Device Identifier07611819518612
UDI-Public(01)07611819518612
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/07/2020
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
Device Operator Health Professional
Device Catalogue Number03.816.002
Device Lot Number8120151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/18/2020
Initial Date Manufacturer Received 08/07/2020
Initial Date FDA Received09/01/2020
Supplement Dates Manufacturer Received09/11/2020
Supplement Dates FDA Received09/30/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RETRACTOR BODY; UNK - SCREWS
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