MAUDE Adverse Event Report: ZIMMER DENTAL IMP,TSV,4.1MM,SBM,16; DENTAL IMPLANT

Catalog Number	TSV4B16
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor reported that the vial caps for the implants were broken/cracked upon receipt.There was no patient involvement.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4) a1: patient identifier unknown / not provided a2: age and date of birth unknown / not provided a3: patient sex unknown / not provided a4: weight unknown / not provided 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.
Additional Manufacturer Narrative
This report is being submitted to relay additional information and device evaluation.The following sections are being reported: b4: date of this report was updated.D9: device availability and return date were updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 111.H6: investigation conclusions code was added: 4307.H10: narrative/data was updated zimvie received the reported implant/vial for evaluation.A visual evaluation was performed, the returned implant packaging was identified as reported.The outer vial's green cap was broken.The outer vial's tamper seal / ring was in a sealed condition.Dhr review was completed for the subject lot number 1265453.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1265453 for similar events and 4 other relevant complaint(s) were identified.The customer did submit images for the reported event.The images showed the implant outer vials green cap was cracked.Based on the investigation and according to the capa, the most likely root cause determined from the investigation was inadequate design of cap and vial system.Therefore, based on the available information, a packaging malfunction did occur.The implant's green cap was cracked while the green caps tamper seal was intact.The reported event was confirmed.This is an ongoing issue which is currently being monitored and a capa has been opened to further contain affected products, evaluate potential root causes, and consider applicable corrective actions.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: IMP,TSV,4.1MM,SBM,16
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19011234
• Report Number: 0002023141-2024-00995
• Device Sequence Number: 8156353
• Product Code: DZE
• UDI-Device Identifier: 00889024019256
• UDI-Public: (01)00889024019256(17)280315(10)1265453
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: K072589
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2024

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: Other
• Device Catalogue Number: TSV4B16
• Device Lot Number: 1265453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2023
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic