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

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.

• 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 Key: 11893739
• MDR Text Key: 253123101
• Report Number: 0008031000-2021-00013
• Device Sequence Number: 1
• Product Code: HAB
• Combination Product (y/n): N
• Reporter Country Code: NI
• Number of Events Reported: 1
• 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 Number: 89-8509-450-60
• Device Lot Number: 5010177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 05/27/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 01/18/2022
• Supplement Dates FDA Received: 07/28/2021; 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1