MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM BATTERY, POWER DRIVER P2

Model Number	N/A
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint #: (b)(4).Report source: (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Event or Problem Description
It was reported that the inner package is damaged.The issue was discovered during an incoming product inspection.There was no patient involvement.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: a5; b4; b5; g3; g6; h1; h2; h3; h6; h10.Pictures of the device were provided.One photo shows the label on the package, which confirms the item/lot number combination that was reported.Visual examination of the provided photos shows wrinkles in the packaging.However, it could not be determined from the provided photos if the bags are torn or seals are compromised.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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 further event information available at the time of this report.

• Brand Name: 1.5MM SYSTEM BATTERY, POWER DRIVER P2
• Common Device Name: BATTERY
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 14626067
• Report Number: 0001032347-2022-00192
• Device Sequence Number: 5001091
• Product Code: GEY
• UDI-Device Identifier: 00841036063504
• UDI-Public: (01)00841036063504(17)230823(10)512550
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2022

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: 08/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 50-1010
• Device Lot Number: 512550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2021
• 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
• 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 Sex: Unknown