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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS; GAUGE DEPTH
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OBERDORF SYNTHES PRODUKTIONS GMBH SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS; GAUGE DEPTH Back to Search Results
Catalog Number 03.111.751
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Device available for evaluation: 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 as no product was received.The investigation could not be completed; 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 that on (b)(6) 2019, the patient underwent open reduction internal fixation surgery for distal radius fracture with a va two-column plate and the soft tissue attachment in question.After closing the incision, the surgeon found that the soft tissue attachment had been broken.The surgeon searched the operation room for the fragment, but he/she couldn¿t find it.On (b)(6) 2019, the surgeon saw the fragment in the patient by x-rays, ct or mri.On the same day, the surgeon got informed consent, and performed the revision surgery to find where the fragment was.During the revision surgery, the surgeon couldn¿t find the fragment, and closed the incision.There was no surgical delay.The surgeon commented that before the first surgery, there was no problem about the soft tissue attachment, and he/she didn¿t know when it was broken.The surgeon also said that the fragment might not enter the body due to its structure.The surgeon had never imagined that the soft tissue attachment was broken.No further information is available.Concomitant device reported: unknown plate (part # unknown, lot # unknown, quantity 1).This complaint involves one (1) device.This report is 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: 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.
 
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Brand Name
SOFT TISSUE ATTCHMT/J-SHAPED F/BONE REDUCTION FORCEPS
Type of Device
GAUGE DEPTH
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9613255
MDR Text Key189495446
Report Number8030965-2020-00527
Device Sequence Number1
Product Code HTJ
UDI-Device Identifier07611819597587
UDI-Public(01)07611819597587
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 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number03.111.751
Was Device Available for Evaluation? No
Date Manufacturer Received03/03/2020
Patient Sequence Number1
Treatment
UNK - PLATES
Patient Outcome(s) Required Intervention;
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