MAUDE Adverse Event Report: ZIMMER SURGICAL SA UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE

Catalog Number	89-8507-400-10
Medical Device Problem Codes	Mechanical Problem (1384); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The device was not returned to the manufacturer at the date of this report.A follow-up medwatch will be submitted once the investigation is completed or if any additional information is received.
Event or Problem Description
It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(4), was jamming and then got stopped while reaming during a hip replacement.A delay of 30 to 45 minutes in the surgery procedure was reported.The reason for the delay is unknown.There was no additional harm or injury to patient/operator reported.
Event or Problem Description
It was reported that the universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6), was jamming and then got stopped while reaming during a hip replacement.A delay of 30 to 45 minutes in the surgery procedure was reported.The reason for the delay is unknown.There was no additional harm or injury to patient/operator reported.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Universal modular electric/battery single trigger handpiece, part number 89-8507-400-10, serial number (b)(6) was not returned for complaint investigation.Therefore, the device could not be visually inspected in an effort to confirm the defect.Design history record review was performed and no issue was discovered during the manufacturing process that could explain the defect reported.A follow-up medwatch will be submitted if the product is returned or if additional information is received.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.The motor was seized.Additionally, there was a leakage issue at the battery support.The motor, screws, and seals were replaced and resolved the reported issue.The potted wired controller, battery support, and seals were updated.Dhr review was performed.Device was 70 months old and is not out of box failure.Device is used for treatment.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• Common Device Name: UNIVERSAL MODULAR ELECTRIC/BATTERY SINGLE TRIGGER HANDPIECE
• 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: 12065771
• Report Number: 0008031000-2021-00022
• Device Sequence Number: 4000199
• Product Code: HAB
• UDI-Device Identifier: 00889024354609
• UDI-Public: (01)00889024354609(11)150302(10)5006009
• Combination Product (Y/N): N
• Initial Reporter Country: ZA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 89-8507-400-10
• Device Lot Number: 5006009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 02/07/2023
• Initial Report FDA Received Date: 06/25/2021
• Supplement Report FDA Received Date: 08/26/2021; 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown