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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN COMP SCREW DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. META-TAN COMP SCREW DRILL; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 71631428
Device Problem Break (1069)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2020
Event Type  Injury  
Event Description
It was reported that during a meta tan procedure, the entry comp reamer broke during use inside of the patient.All of the pieces were recovered.Subsequently, the main comp screw reamer would not fit until lag reamer was used.There was a delay of less than 30 minutes due to this issue.No other complications were reported.
 
Manufacturer Narrative
The device, used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device is broken and has signs of wear and tear from use.According to clinical/medical investigation, the entry comp reamer broke during use inside of the patient.Per communications, all of the pieces were recovered.Subsequently, the main comp screw reamer would not fit, until the surgeon used a lag reamer.There was a reported delay of less than 30 minutes; however, no other complications were reported.Should any additional medical information be provided, this complaint will be re-assessed.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.
 
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Brand Name
META-TAN COMP SCREW DRILL
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10344576
MDR Text Key201017247
Report Number1020279-2020-03576
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00885556158401
UDI-Public00885556158401
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number71631428
Device Catalogue Number71631428
Device Lot Number18HNG0061
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2020
Initial Date Manufacturer Received 07/08/2020
Initial Date FDA Received07/30/2020
Supplement Dates Manufacturer Received12/09/2020
Supplement Dates FDA Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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