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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. POL 5.5 TI CURVED THORACIC PROBE LARG
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ZIMMER BIOMET SPINE INC. POL 5.5 TI CURVED THORACIC PROBE LARG Back to Search Results
Catalog Number 14-500137
Device Problem Fracture (1260)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/19/2019
Event Type  Injury  
Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3012447612-2019-00555.
 
Event Description
It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off.The tips were not able to be retrieved and were retained by the patient.There were no reported surgical delays or additional patient impacts reported.This is report one of two.
 
Manufacturer Narrative
Additional information in b4, d4 (udi is unknown), d10, g4, g7, h2, h3, h4 (mfg date unknown), h6: methods, results, and conclusion codes.The returned device was evaluated.Visual inspection revealed the tip of the device has fractured off.The complaint is confirmed.The dhr for this lot was unable to be found.Actions have been taken as part of capa to address this issue for dhrs going forward.The cause for the failure cannot conclusively be determined.However, possible factors may include: an off axis force applied while the probe was inserted within the bone, very hard bone in the sacrum, and material weakening from previous cases which could cause the probe to fracture when used in this case.
 
Event Description
It was reported that during the procedure, while the surgeon was pulling the probes out, the tips of two probes broke off.The tips were not able to be retrieved and were retained by the patient.There were no reported surgical delays or additional patient impacts reported.This is report one of two.
 
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Brand Name
POL 5.5 TI CURVED THORACIC PROBE LARG
Type of Device
PROBE
Manufacturer (Section D)
ZIMMER BIOMET SPINE INC.
10225 westmoor dr.
westminster CO 80021
MDR Report Key9493598
MDR Text Key173716472
Report Number3012447612-2019-00554
Device Sequence Number1
Product Code HXB
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 06/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number14-500137
Device Lot Number537606
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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