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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. NATURAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ZIMMER, INC. NATURAL NAIL ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 47-2495-340-09
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Pain (1994)
Event Date 07/12/2021
Event Type  malfunction  
Event Description
Narrative from staff: patient underwent a right tibial shaft fracture im nailing. Patient was seen in outpatient clinic, as patient was having increased pain in the distal leg. X-rays revealed a broken intramedullary nail just at the level of the most proximal locking screws. Patient also had some deformity. Surgeon recommended that the nail be revised with a new nail to correct the deformity. Patient underwent removal of implant and exchange nailing. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case. Manufacturer response for rod, fixation, intramedullary and accessories, natural nail® (per site reporter): device provided to representative after case.
 
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Brand NameNATURAL NAIL
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
ZIMMER, INC.
56 east bell drive
warsaw IN 46581
MDR Report Key12459404
MDR Text Key271011203
Report Number12459404
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2495-340-09
Device Catalogue Number47-2495-340-09
Device Lot Number64941866
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/09/2021
Event Location Other
Date Report to Manufacturer09/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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