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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH UNK - NAILS: TIBIAL; NAIL, FIXATION, BONE
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OBERDORF : SYNTHES PRODUKTIONS GMBH UNK - NAILS: TIBIAL; NAIL, FIXATION, BONE Back to Search Results
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
This report is for an unknown nail.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 on (b)(6) 2019 during a tns surgery, surgical procedure is initiated prior to planning with the specialist, the nail to be placed is mounted, the medullary canal is rhymed, the nail is inserted over the protection sheath and additionally the connection piece for the insertion arch is screwed and it is hammered on it to introduce the nail which, upon impact, starts leaving the nail in the middle, the specialist follows the impact directly on the insertion arch on a compress, finishing the complete insertion of the nail, the specialist proceeds to perform the distal block.Under radiographic control, the specialist observes the fracture focus which is distalized with a wide gaf, so it has to be retrospected to reduce the fracture, as we no longer had the connection piece because it was damaged, i told the specialist that the instruments have a compression piece to help reduce the fracture, the doctor reports a bad experience in the handling of this instrument because on one occasion he had used it and the bolt had been bent and for this case the fracture was very separated, where the doctor concludes that the best option is to hit directly with several compresses on the insertion arch, resulting in the damage of the same, so the proximal freehand block was performed.Talking to the specialist assesses what happened and says that the only way to reach the complete reduction of the fracture was the way it was done because otherwise the results would not be favorable for the patient and at the time it was important concomitant devices reported: unknown hammer (part# unknown, lot# unknown, quantity# 1), unknown tibial nail (part# unknown, lot# unknown, quantity# 1).This complaint involves two (2) devices.This is 1 of 1 for report (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.
 
Event Description
This is report 3 of 3 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.
 
Event Description
Concomitant device reported: unknown hammer (part# unknown, lot# unknown, quantity# 1).
 
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.H11: corrected data: g4: awareness date reported on follow up 2 report as november 13, 2019 but should have been december 05, 2019.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
UNK - NAILS: TIBIAL
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
OBERDORF : SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
cl 8 n 50 19
oberdorf NE 4436
SZ  4436
MDR Report Key9311866
MDR Text Key194602189
Report Number8030965-2019-70220
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup,Followup
Report Date 10/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/02/2020
Patient Sequence Number1
Treatment
UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - NAILS: EXPERT TIBIAL
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