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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE
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OBERDORF SYNTHES PRODUKTIONS GMBH UNK - GUIDE/COMPRESSION/K-WIRES; NAIL, FIXATION, BONE Back to Search Results
Device Problems Component Missing (2306); Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - guide/compression/k-wires/unknown lot.Part and lot numbers are unknown; udi number is unknown.Occupation: synthes employee.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 product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 the patient was underwent an unknown surgery, but two sets of guide wire was missing in the box.It was interrupted the surgery and 15 minutes delayed.It was unknown if the surgery completed successfully.The patient outcome was unknown.This is report 02 of 02 of (b)(4).
 
Event Description
This is report 2 of 3 of (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.H6: patient code 3191 used to capture: device failure, surgery prolonged 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.H11: b1, b5, h1: the initial complaint was reviewed and it was determined the complaint event involved devices from depuy joint reconstruction not depuy synthes.It was determined there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device.The reported complaint pertains to a service issue and is not a device related complaint.No patient harm provided.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
The initial complaint was reviewed and it was determined the complaint event involved devices from depuy joint reconstruction not depuy synthes.It was determined there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of a joint reconstruction device after it was released for distribution.There is no report of an adverse event involving a joint reconstruction device.The reported complaint pertains to a service issue and is not a device related complaint.No patient harm provided.
 
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Brand Name
UNK - GUIDE/COMPRESSION/K-WIRES
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key9676914
MDR Text Key189184123
Report Number8030965-2020-00903
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
Report Date 01/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received02/13/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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