MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD; INSTRUMENT, SURGICAL

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Foreign report source: (b)(6).00592704000, milling handpiece, lot # unknown.
Event or Problem Description
It was reported that after a procedure, a staff member attempted to remove the burr from the handpiece but it was jammed.There was no reported impact to the patient.Attempts have been made and no further information has been provided.
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 nick and gouges on the burr, indicative of use.The burr was received seized to the brasseler milling handpiece.Review of the device history records did not identify any deviation or anomalies during manufacturing.The reported products were for compatibility with no issues noted.A definitive root cause was 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.D11: 00592704000, milling handpiece, lot 13010984.

• Brand Name: PATELLO-FEMORAL JOINT (PFJ) MILLING BURR STANDARD
• Common Device Name: INSTRUMENT, SURGICAL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 9770055
• Report Number: 0001822565-2020-00760
• Device Sequence Number: 16768244
• Product Code: HWE
• UDI-Device Identifier: 00889024206144
• UDI-Public: (01)00889024206144
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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 Expiration Date: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 00592705000
• Device Lot Number: 64306679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1