MAUDE Adverse Event Report: ZIMMER BIOMET, INC. EXACT REV FP RASP 10; HIP INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that he product will not be returned to zimmer biomet for the investigation as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2020-01217, 0001825034-2020-01218, 0001825034-2020-01220, 0001825034-2020-01222, 0001825034-2020-01223.
Event or Problem Description
It was reported that patient rasp instruments were found to have fractured on the medial side.It is unknown how and/or when the fractures occurred and no known harm or injury to a patient.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported that during an initial hip procedure, the rasps fractured.No fractured pieces were retained by the patient.Attempts have been made and additional information is unavailable at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: a1; a2; b5; e1; e2; e3; g4; h2 investigation is in process and a follow up will be submitted upon completion.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Photos of product show fracture occurred within the.263 hole and toward the cutting teeth of the instrument.Product was not returned.Dhr was reviewed and no discrepancies were found.The root cause is unable to 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 additional event information to report at this time.

• Brand Name: EXACT REV FP RASP 10
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9859996
• Report Number: 0001825034-2020-01221
• Device Sequence Number: 2787002
• Product Code: HTQ
• UDI-Device Identifier: 00889024584877
• UDI-Public: 00889024584877
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2020

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 Model Number: N/A
• Device Catalogue Number: SSI005610
• Device Lot Number: 97018265
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 07/14/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/24/2020; 07/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR