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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC HUMERAL STEM PROTECTOR; HUMERAL CUT PROTECTOR
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EXACTECH, INC HUMERAL STEM PROTECTOR; HUMERAL CUT PROTECTOR Back to Search Results
Device Problems Detachment Of Device Component (1104); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Joint Disorder (2373); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
The instrument came off in the wound site but was recovered.
 
Manufacturer Narrative
The contribution of the device to the experience reported could not be determined as the device was not returned for evaluation.Additionally, the device specific information was not provided, precluding a review of the device history record.
 
Event Description
The instrument came off in the wound site but was recovered.
 
Manufacturer Narrative
The company investigation shows that the root cause of this event is that the stem protector was not removed and was left in the patient, thus necessitating revision.No corrective action was taken because instruction to remove the stem protector was included in the operative technique.The operative technique guide states to remove the humeral stem protector and assess the position of the stem's spherical bore in relation to the resected surface of the proximal humerus.It is also noted in labeling in the warnings and precautions- only qualified surgeons knowledgeable in anatomy, biomechanics, and reconstructive surgery should use these devices.The surgeon must be fully knowledgeable about all aspects of the shoulder system surgical technique and use these implants in accordance with the respective indications and contraindications.In addition, the surgeon should be fully knowledgeable about the compatibility of system components and use each device accordingly.Finally, the surgeon must be fully knowledgeable about surgical technique, and he/she must be trained according to the proper use of the system instrumentation.This device is used for treatment not diagnosis.Information about this event has been requested, no new information has been provided.Without catalog numbers we cannot obtain the 510(k).Without serial/lot numbers we cannot obtain manufacture date.Corrected data: brand name, not a facility.
 
Event Description
No other information has been provided about the patient or event.
 
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Brand Name
HUMERAL STEM PROTECTOR
Type of Device
HUMERAL CUT PROTECTOR
Manufacturer (Section D)
EXACTECH, INC
2320 nw 66th ct
gainesville FL 32653
MDR Report Key6440024
MDR Text Key71248945
Report Number1038671-2017-00204
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Was Device Available for Evaluation? No
Date Manufacturer Received04/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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