MAUDE Adverse Event Report: ZIMMER BIOMET, INC. HFN LAG SCREW 10.5MM X 80MM; SCREW, FIXATION

Model Number	8145-10-080
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the distributorship that they found air bubbles in the sealing area of the package.No adverse event has been reported as a result of the malfunction.
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm, cat: 814510080 lot: yg1121280b hfn lag screw 10.5mm x 80mm.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.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
Upon receipt of additional information, it has been confirmed that the product was found to be conforming the initial report was forwarded in error and should be voided.
Additional Manufacturer Narrative
Visual examination of the returned product found bubbles in the pouch seal.Seal tests were performed in which all results are within the acceptable limits.The product was found to be conforming.The initial report was forwarded in error and should be voided.Further, the event did not contribute to a serious injury; therefore, this would not be considered a reportable event.

• Brand Name: HFN LAG SCREW 10.5MM X 80MM
• Common Device Name: SCREW, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 14222446
• Report Number: 0001825034-2022-00954
• Device Sequence Number: 5480053
• Product Code: HSB
• UDI-Device Identifier: 00887868038983
• UDI-Public: (01)00887868038983(17)231222(10)YG1121280B
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K100238
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

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 Model Number: 8145-10-080
• Device Catalogue Number: 814510080
• Device Lot Number: YG1121280B
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown