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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION AIMING DEVICE HOLDER; IMPACTOR
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OBERDORF SYNTHES PRODUKTIONS GMBH SYNFIX EVOLUTION AIMING DEVICE HOLDER; IMPACTOR Back to Search Results
Catalog Number 03.835.004
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.(b)(6).The investigation could not be completed, no product was received; 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 on an unknown date that, during the surgery, the device holder was got stuck together.The surgeon used similar device to complete the procedure.There was no delay reported.There were no patient consequences.This complaint involves one (1) device.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.
 
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, h4, h6- the synfix® evolution aiming device holder (part # 03.835.004, lot # 972973) was received at us cq.Upon visual inspection, no visual defects were observed on the device.The functional test performed on the received device indicated that the outer shaft on the aiming device holder was stiff and very difficult to operate.Components in the device were not able to be separated.This is consistent with the reported complaint condition; the complaint was able to be replicated.Therefore, the complaint is confirmed.The overall complaint was confirmed for the received device as a component in the device was jammed.While no definitive root cause could be determined it is possible that the device encountered unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part: 03.835.004, lot: l972973, manufacturing site: hägendorf, release to warehouse date: 29.August 2018.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
SYNFIX EVOLUTION AIMING DEVICE HOLDER
Type of Device
IMPACTOR
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key10125393
MDR Text Key194321919
Report Number8030965-2020-03973
Device Sequence Number1
Product Code HWA
UDI-Device Identifier07611819677043
UDI-Public07611819677043
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,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.835.004
Device Lot NumberL972973
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2020
Date Manufacturer Received07/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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