MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ZIMMER M/L TAPER HIP PROTHESIS SYSTEM RASP LONG POST SIZE 4; INSTRUMENT, HIPS

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: country: china.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.
Event or Problem Description
It was reported that tip of rasp fractured and was suspected to be a retained foreign body in the patient.There was no reported adverse patient impact, and no surgical intervention to remove the foreign body.The patient was not symptomatic.There was no surgical delay.Surgical technique for the product was utilized.No additional information was available.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional and corrected information.The following sections were updated: b4;d9;g3;h2;h3;h6.The following section was corrected: d1.H6: component code: mechanical (g04) rasp.Visual examination of the returned product identified that the rasp cutting teeth were dull and worn.The flat surface around the etch also showed wear from previous uses.The distal tip was confirmed fractured.The fractured piece(s) were not returned for evaluation.No other damage was noted.The device history records were reviewed for deviations, anomalies and similar events.Tips of the rasps breaking were found in the device history review; however, the investigation determined that those devices met product specifications.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.Medical records were not provided.A definitive root cause cannot be determined.The complaint is confirmed based on the returned, fractured device.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.

• Brand Name: ZIMMER M/L TAPER HIP PROTHESIS SYSTEM RASP LONG POST SIZE 4
• Common Device Name: INSTRUMENT, HIPS
• 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: 19691801
• Report Number: 0001822565-2024-02260
• Device Sequence Number: 18175531
• Product Code: LZO
• UDI-Device Identifier: 00889024132023
• UDI-Public: (01)00889024132023(10)63319839
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K192660
• 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): 11/15/2024

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 Model Number: N/A
• Device Catalogue Number: 00771200460
• Device Lot Number: 63319839
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male