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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3MMX1000MM BALL TIP GUIDE ROD PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. 3MMX1000MM BALL TIP GUIDE ROD PLATE, FIXATION, BONE Back to Search Results
Catalog Number 71631626
Device Problems Partial Blockage (1065); Fracture (1260)
Patient Problems Osteolysis (2377); No Code Available (3191)
Event Date 10/30/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported a surgical delay greater than 30 minutes occurred due to stem guide being blocked from removal after implantation of nail. The nail and stem guide were removed and another product was used.
 
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Brand Name3MMX1000MM BALL TIP GUIDE ROD
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
markus poettker
schachenallee 29
aarau, TN 5001
SZ   5001
0416283206
MDR Report Key6218464
MDR Text Key63734579
Report Number1020279-2017-00011
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K123055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician Assistant
Device Catalogue Number71631626
Device Lot Number16ESM0116
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/29/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 01/03/2017 Patient Sequence Number: 1
Treatment
NAIL PART#71655136 LOT#15MT62509
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