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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL TAP 4.5MM; TAP, BONE

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DEPUY SPINE INC MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL TAP 4.5MM; TAP, BONE Back to Search Results
Model Number 288310045
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2022
Event Type  malfunction  
Event Description
Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, when preparing for a spinal fusion procedure for a c1 fracture, it was found that a substance such as bone debris was adhering to the screw in question.The screw had been cleansed and sterilized at the hospital the day before the operation.The substance was removed, and the screw was cleansed and sterilized.The screw was used for the operation, and the surgery was completed successfully without any delay.This event did not affect the operation.No further information is available.This report involves one mountaineer oct spinal system occipital tap 4.5mm.This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.A review of the receiving inspection (ri) for the viper2 final tightener driver was conducted identifying that lot number x0208 was released in a single batch.Batch1: lot qty of (b)(4) units was released on 04/28/2008 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that there was foreign substance adhered to the threaded end of the oc 4.5 tap, p/n: 288310045.No other problems identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for oc 4.5 tap, p/n: 288310045.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
MOUNTAINEER OCT SPINAL SYSTEM OCCIPITAL TAP 4.5MM
Type of Device
TAP, BONE
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key15813391
MDR Text Key307669093
Report Number1526439-2022-01964
Device Sequence Number1
Product Code HWX
UDI-Device Identifier10705034221687
UDI-Public10705034221687
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number288310045
Device Catalogue Number288310045
Device Lot NumberX0208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2022
Initial Date FDA Received11/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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