MAUDE Adverse Event Report: ZIMMER DENTAL RETAINING SQUARE RATCHET; DENTAL RATCHET

Catalog Number	RSR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided.D4: expiration date: unknown / not provided.
Event or Problem Description
The ratchet wrench does not turn and does not allow the implant to be placed in #47.Procedure was not completed.Pain was reported as a result of the event.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem g3: date received by manufacturer g6: type of report h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: adverse event problem h10: additional narrative.After additional information was received on january 2, 2025, it was determined that this event no longer meets the criteria of a malfunction that if it were to recur would cause or contributed to a death and / or serious injury.As a result, the prior submission for mfr- 0002023141-2025-00074 submitted on january 9, 2025, is no longer considered a reportable event by the manufacturer and no further report will be submitted for this event.
Event or Problem Description
The ratchet wrench does not turn and does not allow the implant to be placed in #47.Procedure was not completed.Pain was reported as a result of the event.On a follow up received on (b)(6) 2025 doctor confirmed that the implant has been placed with another ratchet wrench.

• Brand Name: RETAINING SQUARE RATCHET
• Common Device Name: DENTAL RATCHET
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 21109800
• Report Number: 0002023141-2025-00074
• Device Sequence Number: 8719391
• Product Code: NDP
• UDI-Device Identifier: 00889024016736
• UDI-Public: (01)00889024016736(17)991231(10)2120012559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2025

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 Catalogue Number: RSR
• Device Lot Number: 2120012559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2024
• 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
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic