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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER, INC. FLEXIBLE CANNULATED REAMER 6.5 MM DIAMETER PROSTHESIS, ELBOW

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ZIMMER, INC. FLEXIBLE CANNULATED REAMER 6.5 MM DIAMETER PROSTHESIS, ELBOW Back to Search Results
Model Number N/A
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/09/2017
Event Type  Injury  
Manufacturer Narrative
Reported event was unable to be confirmed due to limited information received from the customer. Device history record (dhr) was reviewed and no discrepancies were found. Review of the complaint history determined that no further action(s) is/are required. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported that during an elbow procedure, the reamer shaft detached from the mating instrument and handle. A jacob's chuck was utilized to remove reamer head and shaft from the patient's bone. Attempts have been made, however additional information is unavailable at this time.
 
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Brand NameFLEXIBLE CANNULATED REAMER 6.5 MM DIAMETER
Type of DevicePROSTHESIS, ELBOW
Manufacturer (Section D)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer (Section G)
ZIMMER, INC.
1800 west center street
warsaw IN 46580
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key6637079
MDR Text Key117964518
Report Number0001822565-2017-04016
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
PK123862
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 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00840107203
Device Lot Number63134914
Other Device ID NumberN/A
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/20/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/29/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 06/13/2017 Patient Sequence Number: 1
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