MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER NATURAL NAIL SYSTEM 5.0MM CORTICAL SCREW; ROD, FIXATION

Model Number	N/A
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent initial right hip osteosynthesis with a trochanteric nail approximately 3 and a half years ago due to a comminuted fracture.Subsequently, the patient was revised about 2 years ago due to pain and pseudoarthrosis.The nail was removed without difficulty, and a total hip arthroplasty was performed without complications.Attempts have been made and there is no further information at this time.
Additional Manufacturer Narrative
(b)(4).Updated: a1, a3, b4, b5, d1, d2, e1, g3, h1, h2, h11.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
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).D10 - medical product: catalog #: 47248510010, znn, cmn lag screw, 10.5 mm, 100 mm, lot #: 3076664.Catalog #: 47249321210, cmn femoral nail, ccd 130, right, 10 mm, 21.5 cm, lot #: 3076099.Catalog #: 47249003004, standard 3.0mm anti-rotation pin, lot #: 65166295.G2: france.H3: customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed as medical records/radiographs were provided and reviewed and identified the following: general anesthesia, posterolateral approach, revision due to pain and pseudoarthrosis, znn removed without difficulty, no significant findings dictated regarding implants, non-zb components implanted without complications.Visual examination of the returned product identified a portion of the thread form is damaged.Product identifiers are conforming to print specifications.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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
No further event information available at the time of this report.

• Brand Name: ZIMMER NATURAL NAIL SYSTEM 5.0MM CORTICAL SCREW
• Common Device Name: ROD, FIXATION
• 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: 19467059
• Report Number: 0001822565-2024-01876
• Device Sequence Number: 3455949
• Product Code: HSB
• UDI-Device Identifier: 00889024094017
• UDI-Public: (01)00889024094017(17)310803(10)65167444
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/22/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 47248403550
• Device Lot Number: 65167444
• 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: 05/24/2024
• Supplement Date Received by Manufacturer: 06/10/2024; 10/04/2024
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/03/2024; 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2021
• 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: SEE H10
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 52 KG