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

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.

• Brand Name: BLADE HOLDER-LEFT
• Type of Device: RETRACTOR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10480283
• MDR Text Key: 208806036
• Report Number: 8030965-2020-06535
• Device Sequence Number: 1
• Product Code: GAD
• UDI-Device Identifier: 07611819518612
• UDI-Public: (01)07611819518612
• 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: 08/07/2020

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 Number: 03.816.002
• Device Lot Number: 8120151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/01/2020
• Supplement Dates Manufacturer Received: 09/11/2020
• Supplement Dates FDA Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RETRACTOR BODY; UNK - SCREWS