MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.5 MM / 2.7 MM PLATE REDUCTION INSTRUMENT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	00236001101
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Osteopenia/ Osteoporosis (2651); Foreign Body In Patient (2687)
Date of Event	11/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure on an unknown date, the instrument fractured during reduction and part of the device remained in the patient.There are currently no plans for an additional surgery to remove the fractured piece at this time, as the surgeon indicated the patient is not experiencing any harm as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in france.Product has been returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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
This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified approximately 1.5 inches of the threaded end of the instrument is fractured and missing.Damage is seen near the fracture.The device exhibits wear and tear indicating repeated use during a potential field age of 5 years.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: two views of the distal right femur demonstrate a plate and screw fixation device along the lateral distal femoral diaphysis cortex with displaced transverse fracture involving the mid to distal diaphysis of the femur.Surgical skin staples.No knee dislocation.Osteopenia.No retain foreign body is seen.There does appear to be a displaced mid to distal femoral diaphysis fracture present.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.5 MM / 2.7 MM PLATE REDUCTION INSTRUMENT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 18345507
• Report Number: 0001822565-2023-03611
• Device Sequence Number: 6222437
• Product Code: LXH
• UDI-Device Identifier: 00889024059764
• UDI-Public: (01)00889024059764(10)64238188
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00236001101
• Device Lot Number: 64238188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• 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: 11/23/2023
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2018
• 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: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 87 YR
• Patient Sex: Male