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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL OSCILLATING SAW ATTACHMENT

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ZIMMER SURGICAL SA UNIVERSAL OSCILLATING SAW ATTACHMENT Back to Search Results
Catalog Number 89-8509-450-60
Device Problems Mechanical Problem (1384); Device-Device Incompatibility (2919)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/12/2019
Event Type  Injury  
Manufacturer Narrative
Complaint number (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be sent if the product is returned or if additional information is received.
 
Event Description
It was reported that the single trigger handpiece stops driving.Moreover, the reciprocating saw was not sitting into the hand piece and the oscillating saw was not holding blade.4 devices were referenced for this event: universal modular electric/battery single trigger handpiece part number 89-8507-400-10 serial number (b)(4).Aseptic transfer kit housing part number 89-8510-440-10 with lot number 5010187.Reciprocating saw attachment part number 89-8509-451-20 serial number (b)(4).Oscillating saw attachment part number 89-8509-450-60 serial number (b)(4).The following report is relative to the oscillating saw attachment part number 89-8509-450-60 serial number (b)(4).The event occurred during surgery.An extension of surgery of at least 60 minutes was reported.There was no additional harm or injury to patient/operator reported.
 
Manufacturer Narrative
(b)(4).After several attempts, the oscillating saw attachment part number 89-8509-450-60, serial number (b)(6) was not returned for complaint investigation.A device history records review was performed for this product part number 89-8509-450-60, serial number (b)(6).No issue was found during the manufacturing process that could explain the defect reported.
 
Event Description
It was reported that the single trigger handpiece stops driving.Moreover, the reciprocating saw was not sitting into the hand piece and the oscillating saw was not holding blade.4 devices were referenced for this event: universal modular electric/battery single trigger handpiece part number 89-8507-400-10, serial number (b)(6).Aseptic transfer kit housing part number 89-8510-440-10 with lot number 5010187.Reciprocating saw attachment part number 89-8509-451-20, serial number (b)(6).Oscillating saw attachment part number 89-8509-450-60, serial number (b)(6).The following report is relative to the oscillating saw attachment part number 89-8509-450-60, serial number (b)(6).The event occurred during surgery.An extension of surgery of at least 60 minutes was reported.There was no additional harm or injury to patient/operator reported.
 
Event Description
It was reported that the single trigger handpiece stops driving.Moreover, the reciprocating saw was not sitting into the hand piece and the oscillating saw was not holding blade.4 devices were referenced for this event: universal modular electric/battery single trigger handpiece part number 89-8507-400-10 serial number (b)(6).Aseptic transfer kit housing part number 89-8510-440-10 with lot number 5010187.Reciprocating saw attachment part number 89-8509-451-20 serial number (b)(6).Oscillating saw attachment part number 89-8509-450-60 serial number (b)(6).The following report is relative to the oscillating saw attachment part number 89-8509-450-60 serial number (b)(6).The event occurred during surgery.An extension of surgery of at least 60 minutes was reported.There was no additional harm to patient/operator reported.
 
Manufacturer Narrative
(b)(4).Oscillating saw attachment part number 89-8509-450-60 serial number (b)(6) was returned for complaint investigation.Visual and functional tests were performed.Upon receipt, it was confirmed that the eccentric system and the ratchet system was malfunctioning.As repair, the oscillating system, the eccentric system, the ratchet system were replaced.Device passed all final tests and was returned to the customer.A device history records review was performed for this product part number 89-8509-450-60 serial number (b)(6).No issue was found during the manufacturing process that could explain the defect reported.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
 
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Brand Name
UNIVERSAL OSCILLATING SAW ATTACHMENT
Type of Device
UNIVERSAL OSCILLATING SAW ATTACHMENT
Manufacturer (Section D)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
plan-les-ouates, geneva 1228
SZ  1228
Manufacturer (Section G)
ZIMMER SURGICAL SA
3, ch. du pre fleuri
plan-les-ouates, geneva 1228
SZ   1228
Manufacturer Contact
christina arnt
56 e. bell drive
warsaw, IN 46582
5745273773
MDR Report Key11893739
MDR Text Key253123101
Report Number0008031000-2021-00013
Device Sequence Number1
Product Code HAB
Combination Product (y/n)N
Reporter Country CodeNI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 01/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number89-8509-450-60
Device Lot Number5010177
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/17/2021
Initial Date FDA Received05/27/2021
Supplement Dates Manufacturer Received05/17/2021
01/18/2022
Supplement Dates FDA Received07/28/2021
01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/10/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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