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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FLEXIBLE SHAFT W/CIR CONNECTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

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SMITH & NEPHEW, INC. FLEXIBLE SHAFT W/CIR CONNECTOR; PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED Back to Search Results
Model Number 71118200
Device Problem Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/19/2020
Event Type  Injury  
Event Description
It was reported that during procedure and inside the patient the flexible shaft w/cir connector broke off while reaming canal of femur.Procedure was finished using an s+n backup device.No surgical delays reported.
 
Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection confirms the flexible shaft is bent in the middle of the device.Also the visual confirms the end of the device broke off.The broken piece was not returned for evaluation.The piece that broke off holds the lot number.The lot number is not available for this device.The device exhibits signs of extreme wear/usage.A medical investigation was conducted and this case reports the flexible shaft w/cir connector broke off while reaming canal of femur.Per complaint details, there was no patient injury, and the procedure was completed without delay, using a backup device.Since no patient harm is alleged, no further clinical assessment is warranted.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of risk management files found that the reported failure was documented appropriately.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
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Brand Name
FLEXIBLE SHAFT W/CIR CONNECTOR
Type of Device
PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10815941
MDR Text Key215484907
Report Number1020279-2020-06340
Device Sequence Number1
Product Code HSD
UDI-Device Identifier03596010436528
UDI-Public03596010436528
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 11/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number71118200
Device Catalogue Number71118200
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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