MAUDE Adverse Event Report: ZIMMER SURGICAL, INC. DYNABLATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	R10005
Medical Device Problem Codes	Fracture (1260); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation into the reported event has been initiated under (b)(4).Once the investigation has been completed, a follow up report will be submitted with the investigation results and any actions taken by the manufacturer.G2 country: australia.
Event or Problem Description
It was reported that towards the end of an arthroscopic shoulder procedure, the tip of the dynablator had broken off inside the patient.Surgeon looked inside the patient for piece(s) that separated from dynablator, staff inspected suction channel and line and could not locate it/them.There was no patient harm/injury reported.The medical professional indicated that an unanticipated surgical complication occurred.There was a surgical delay of 30 minutes, and the surgery was completed with another device.Due diligence is complete, no further information is available.
Additional Manufacturer Narrative
This complaint is recorded by zimmer biomet under (b)(4).Visual inspection of the device found the ceramic tip was heavily worn and discolored and the end of the tip was broken off.There was also heavy wear and scratching around the metal sheath.Review of the device history record identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The event is confirmed.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
There is no additional information regarding the event.

• Brand Name: DYNABLATOR
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer (Section G): ZIMMER SURGICAL, INC.; 200 west ohio avenue; dover OH 44622
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell drive; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20295253
• Report Number: 0001526350-2024-01124
• Device Sequence Number: 17941947
• Product Code: HRX
• UDI-Device Identifier: 00859273007052
• UDI-Public: (01)00859273007052(17)241129(10)F22L29-01
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K233493
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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 Expiration Date: 11/29/2024
• Device Catalogue Number: R10005
• Device Lot Number: F22L29-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BURR 5.0MMPN: R10021SN: (B)(6); EXOFLOWPN: R10017LN: F23H05-01; EXPRESSBRAIDPN: 110003463LN: 802940; UNICORTICAL FIXPN: 110017314LN: 66444560
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female