MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR 2.2MM DRILL BIT STERILE; BIT, DRILL

Model Number	212000022
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the incoming inspection, they found a scratch on the sterile package.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).G2: foreign- japan.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.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned product found a scratch on the sterile packaging that is not acceptable per manufacturing procedure, however the sterility has not been breached.This complaint has been confirmed by evaluation of the returned product.Review of the device history records identified no deviations or anomalies during manufacturing.The condition of the device when it left zimmer biomet is considered non-conforming to specification.The root cause of the reported event can be attributed to packaging operator not following the work instructions provided.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 is available at the time of this report.

• Brand Name: DVR 2.2MM DRILL BIT STERILE
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16983150
• Report Number: 0001825034-2023-01046
• Device Sequence Number: 15160693
• Product Code: HTW
• UDI-Device Identifier: 00887868446054
• UDI-Public: (01)00887868446054(17)330412(10)65985142
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 212000022
• Device Catalogue Number: 212000022
• Device Lot Number: 65985142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2023
• 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
• Patient Sex: Unknown