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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH TI USS LOW PROFILE FRACTURE CLAMP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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SYNTHES GMBH TI USS LOW PROFILE FRACTURE CLAMP; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 498.831S
Device Problems Compatibility Problem (2960); Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/26/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: additional procode: mni, mnh, kwp, kwq.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020 during a posterior spinal fusion procedure, the nut on the rod clamp turned idly and was not able to be fixed.There was a surgical delay of less than thirty (30) minutes.There is no further information available.This report is for one (1) ti uss low profile fracture clamp.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.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.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.
 
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.H10 additional narrative: h3, h6: part # 50132765 (backe component) lot # 70p8517 manufacturing site: mezzovico release to warehouse date: october 2, 2020 a manufacturing record evaluation was performed for the not sterile lot number, and no non-conformances were identified.The analysis results found that the screw in yellow color has a badly deformed thread and as well a deformed hexagonal screw head.In addition, the counterpart, in blue color, of the screw has a deformed inner thread.The yellow and the blue part got sold as one article.Furthermore, the implant is in a used condition, with some spots of discoloration, from the period of implantation and reprocessing.The investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no functional test or dimensional inspection is needed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.The complaint is confirmed as the part is damaged as reported.The review of the production history revealed that this item was manufactured according to the specifications.No manufacturing related issues that would have contributed to this complaint condition were found.Moreover, a review of our complaints data base shows, that there are no other complaints for this issue from this article and lot number.Unfortunately, we are not able to determine the exact reason for this occurrence, but we have to assume that during the operation an application error may have taken place or/and that high applied mechanical force could have led to this damage.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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
TI USS LOW PROFILE FRACTURE CLAMP
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key11214589
MDR Text Key228551674
Report Number8030965-2021-00521
Device Sequence Number1
Product Code NKB
UDI-Device Identifier07611819182288
UDI-Public(01)07611819182288
Combination Product (y/n)N
PMA/PMN Number
K082572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number498.831S
Device Lot Number70P8517
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2021
Date Manufacturer Received04/12/2021
Patient Sequence Number1
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