MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK DIST TIB MED LT 9H STE; PIN, FIXATION

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical products: cat: 856211009 lot: 762010 lock dist tib med lt 9h ste.Cat: 856211009 lot: 762010 lock dist tib med lt 9h ste.Cat: 856211009 lot: 762010 lock dist tib med lt 9h ste.Report source: 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01915, 0001825034 - 2022 - 01985, 0001825034 - 2022 - 01987.

Event Description

It was reported that the sterile package was not vacuumed.No adverse events have been reported as a result of the malfunction.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual evaluation of the returned product found the vacuum seal was no longer intact.The product has been found to be non-conforming.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 Description

Upon evaluation of the returned product, it has been determined that the packaging meets the standards of inspection criteria.The initial report was forwarded in error and should be voided.

Manufacturer Narrative

Upon evaluation of the returned product, it has been determined that the packaging meets the standards of inspection criteria.This complaint cannot be confirmed as the product was found to be conforming.The initial report was forwarded in error and should be voided.

• Brand Name: LOCK DIST TIB MED LT 9H STE
• Type of Device: PIN, FIXATION
• 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: 15335655
• MDR Text Key: 302427541
• Report Number: 0001825034-2022-01986
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 00887868449765
• UDI-Public: (01)00887868449765(17)320718(10)762010
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 856211009
• Device Lot Number: 762010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE NARRATIVE IN H10