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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH ROD CUTTER; CUTTER,WIRE
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OBERDORF SYNTHES PRODUKTIONS GMBH ROD CUTTER; CUTTER,WIRE Back to Search Results
Catalog Number 388.720
Device Problems Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 03/22/2019
Event Type  Injury  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 argentina as follows: it was reported that a patient underwent surgery on (b)(6) 2019 to correct scoliosis.During the surgery, the front grips of the bolt cutter were extremely worn and open so that it was impossible to perform the gripping maneuvers.The cut bar was in bad condition and was not suitable for cutting cobalt chrome bars.There was bending of the cutting edge of the bars which made it impossible to cut with the in-situ bars.When trying to make the final adjustment of the system, the anti-torque of the bolt cutter did not work.The shear did not cut properly, that's why the inners had to be removed to cut the bar outside.When trying to make the final adjustment, due to the wear of the unknown screwdriver it was impossible to reach the end of the adjustment because it rounded the nuts of the system.The final adjustment was attempted, however eight (8) unknown consecutive nuts were rounded (inners were nicked).Procedure was not successfully completed.There was a surgical delay of one (1) hour.Patient outcome is reported as not being able to fully correct the deformity and not able to make the adjustment.This report is for one (1) bolt cutter.This is report 1 of 1 for complaint (b)(4).
 
Event Description
It was further reported that the final adjustment was attempted, and six (6) consecutive nuts were rounded by the bad condition of the nuts but it was also mentioned that eight (8) were damaged and considered unusable since the inners were nicked.The procedure was terminated but the result was not optimal because it was not possible to finish correcting the deformity.From a correction of a curve of 70 degrees that had to be taken to 15 degrees, it was possible to take it up to 40 degrees.
 
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.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.Both distal cutting jaws on a returned device have a portion of the cutting surface broken off and deform on both sides of the jaws.The fracture patterns are circular suggesting that the device broken while cutting a circular object (bolt).Device was tested for opening and closing functionality and it was determined to function perfectly after 10-15 attempts.Device will not open or close can not be confirmed.An accurate dimensional inspection was not possible due to the post manufacturing damage on tapered surfaces.Document/specification review: rod/cutter design drawing 388_72 revision h was reviewed during this investigation.No product design issues or discrepancies were observed during this investigation.Conclusion: a definitive root cause for the damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified as a result of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Part number: 388.720, lot number: t165145, manufacturing site: tuttlingen, release to warehouse date: 15-may-2018.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.
 
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.Upon receipt of the device, during initial visual inspection, the device was noted to be broken around the blades.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.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
Concomitant devices reported: expedium torque shaft (part #: 279712600, lot #: unknown, quantity: 1), expedium single innie set screw (part #: 179702000, lot #: unknown, quantity: 8).
 
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Brand Name
ROD CUTTER
Type of Device
CUTTER,WIRE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8540453
MDR Text Key142779097
Report Number8030965-2019-63065
Device Sequence Number1
Product Code HXZ
UDI-Device Identifier07611819710504
UDI-Public(01)07611819710504
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,Followup,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number388.720
Device Lot NumberT165145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/03/2019
Date Manufacturer Received06/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
EXPEDIUM SINGLE INNIE SET SCREW; EXPEDIUM TORQUE SHAFT
Patient Outcome(s) Required Intervention;
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