MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM TAPER REAMER 14.5MM; ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE?TRAUMA

Catalog Number	00249001414
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D10: medical products: item#: (b)(4), entry reamer 8 mm; lot#: 64719255.G2: foreign: south africa.H6: component codes: mechanical (g04) - drill.Visual examination of returned device shows wear & tear that indicates repeated use.The end of the cutting feature of the device is damaged.Material is missing from the cutting end.Product identifiers are conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.Medical records were not provided.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that while the surgeon was using the instrument, the instrument became worn and fractured as the bone was extremely hard.The surgeon was able to complete the surgery with the instrument.There was no report of harm or foreign body retained by the patient.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM TAPER REAMER 14.5MM
• Common Device Name: ORTHOPAEDIC PROSTHESIS IMPLANTATION POSITIONING INSTRUMENT, REUSABLE?TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 20169397
• Report Number: 0001822565-2024-02886
• Device Sequence Number: 8069687
• Product Code: HTO
• UDI-Device Identifier: 00889024063273
• UDI-Public: (01)00889024063273(10)65322431
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00249001414
• Device Lot Number: 65322431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2024
• 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: 09/06/2024
• Initial Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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 Sex: Unknown