MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCKING CALC PLT SM LT STE; PLATE, FIXATION

Model Number	8166-08-001
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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 mdr will be submitted.
Event or Problem Description
It was reported that during the inspection, debris was found in the sterile package.There was no patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10 complaint sample was evaluated and the reported event was confirmed.Visual examination of the returned product found an unknown piece of debris.The debris is located within the inner pouch and part sleeve device history record (dhr) was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet is non-conforming to specification.The root cause of the reported event is the 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 additional event information is available at the time of this report.

• Brand Name: LOCKING CALC PLT SM LT STE
• Common Device Name: PLATE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 11941026
• Report Number: 0001825034-2021-01672
• Device Sequence Number: 19937769
• Product Code: HRS
• UDI-Device Identifier: 00887868445576
• UDI-Public: (01)00887868445576(17)310227(10)983190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093474
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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: 8166-08-001
• Device Catalogue Number: 816608001
• Device Lot Number: 983190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/04/2021
• Supplement Report FDA Received Date: 07/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1