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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL
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OBERDORF SYNTHES PRODUKTIONS GMBH 1.25MM THREADED GUIDE WIRE 150MM; WIRE,SURGICAL Back to Search Results
Catalog Number 292.620
Device Problems Break (1069); Entrapment of Device (1212); Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/30/2019
Event Type  Injury  
Manufacturer Narrative
Additional pro-coce: hty.Complainant part is not expected to be returned for manufacturer review / investigation.Occupation: synthes rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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: when drilling, the pin fractures, leaving a fragment in the patient.The remaining fragment was sent with the driver that picked up the equipment.Remission (b)(4) cannulated 4.0 rotation.This complaint involves one (1) device.This report is 1 of 1 for remission (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.Corrected information: initial reporter updated.Contact manufacturer updated.Device code updated from 1261 to 1069 and 1212.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.E1: phone #: (b)(6).H3, h6: investigation summary 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 h3, h4, h6: a review of the device history.Device history lot a dhr review was not performed for this pi.This lot was not manufactured at the monument facility.There are no historical records for this part number.Please investigate and reassign to the correct facility.22-aug-2019 by: j.Brooks part number: 292.620, lot number: 3l41209, part manufacture date: n/a, manufacturing location: n/a, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record could not be performed as the product was not returned and the lot number provided does not match the part number.20-sep-2019: rhess6 part: 292.620, lot: 3l41209, manufacturing site: balsthal, release to warehouse date: 07.Feb.2019.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history review.A dhr review was not performed for this pi.This lot was not manufactured at the monument facility.There are no historical records for this part number.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
1.25MM THREADED GUIDE WIRE 150MM
Type of Device
WIRE,SURGICAL
Manufacturer (Section D)
OBERDORF SYNTHES PRODUKTIONS GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
MDR Report Key8970960
MDR Text Key156787724
Report Number8030965-2019-68050
Device Sequence Number1
Product Code LRN
UDI-Device Identifier07611819013841
UDI-Public(01)07611819013841
Combination Product (y/n)N
PMA/PMN Number
PRE-AMEN
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 08/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number292.620
Device Lot Number3L41209
Date Manufacturer Received10/15/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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