MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TRIAL IMPLANT HOLDER; TEMPLATE

Catalog Number 03.670.204

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is synthes distributor.Device is not distributed in the united states, but is similar to device marketed in the usa.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 Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that on an unknown date, the trial implant holder was bent.It is not known when the issue occurred or if there was patient involvement.This report is for one (1) trial implant holder 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.A device history record (dhr) review was conducted: part: 03.670.204.Lot: 9717116.Manufacturing site: hägendorf.Release to warehouse date: 18.Nov.2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.A product investigation was conducted.The returned prodisc-c vivo holder was forwarded to the spine sustaining center for evaluation.The statement below is a summary of their investigation.The received condition of the prodisc-c vivo holder are concordant with the complaint description and the complaint condition is confirmed.The holding part of the instrument is bent backwards.Therefore, the function of the instrument is no longer given.As the complaint description is not detailed enough, no clear statement can be given.It can be assumed that strong force was put on the holding device while inserting the trial implant led to this complaint.This lot was manufactured in november 2015 according to the specification.The review of the production history revealed that this instrument was manufactured according to the specifications.The parts conformed to dimensional / visually specifications at the time of manufacturing and passed inspection requirements.No manufacturing related issues that would have contributed to this complaint were found.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.

Event Description

01/03/2018: updated event description due to additional information received on january 3, 2019: device report from synthes europe reports an event in germany as follows: it was reported that on an unknown date, the prodisc-c vivo holder for trial implant was bent.The instrument came from sterilization process and was noted from the sterilization department.There was no patient involvement.

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.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: TRIAL IMPLANT HOLDER
• Type of Device: TEMPLATE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8197570
• MDR Text Key: 131485819
• Report Number: 8030965-2018-59254
• Device Sequence Number: 1
• Product Code: HWT
• UDI-Device Identifier: 07611819380936
• UDI-Public: (01)07611819380936
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2018

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: 03.670.204
• Device Lot Number: 9717116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Manufacturer Received: 11/30/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/03/2019; 02/13/2019
• Supplement Dates FDA Received: 01/22/2019; 03/01/2019
• Patient Sequence Number: 1