MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 2.7X160MM CALIBRATED DRILL STE; TRAUMA, INSTRUMENT

Model Number	2142-27-160
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Report source foreign: (b)(6).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 report will be submitted.
Event or Problem Description
It was reported that there was debris found in the sterile packaging during incoming inspection.There was no patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual evaluation of the returned products identified that there is debris inside the sterile packages.The complaint has been confirmed by visual evaluation.Device history record was reviewed and no discrepancies were found.These products likely left zimmer biomet control non-conforming.The root cause of the reported issue is attributed to manufacturing deficiency.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.

• Brand Name: 2.7X160MM CALIBRATED DRILL STE
• Common Device Name: TRAUMA, INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11466883
• Report Number: 0001825034-2021-00740
• Device Sequence Number: 11561109
• Product Code: HTW
• UDI-Device Identifier: 00887868446733
• UDI-Public: (01)00887868446733
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 2142-27-160
• Device Catalogue Number: 214227160
• Device Lot Number: 496900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1