MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE; DENTAL ABUTMENT SCREW

Model Number	HLA3/5
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a follow-up examination, the patient complained of the crown loosening.The abutment screw was found broken after examination.The screw was not removed.The implant was removed.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Patient identifier: (b)(6).Weight unknown / not provided (b)(6), impl tapered scr-v sbm 3.7mm 3.5mm 13mm/lot# 63774439.Zip code: (b)(6).Additional pma/510(k) number ¿ k013227|k953101.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: h6: type of investigation codes were added: 4109, 4111 and 3331.H6: investigation findings code was added: 3252.H6: investigation conclusions code was added: 4307.Zimvie received one (1) abutment/screw for evaluation.Visual evaluation was performed, ¿signs of use, bone debris on external threads.The abutment showed signs of use.Dhr review was completed for the subject lot number 63879646.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 63879646 for similar events and no other complaint was identified.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was design error & excessive loading on abutment/implant assembly.Therefore, based on the available information, device malfunction did occur, as there was a fractured screw in the implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
Event or Problem Description
No additional event information received at the time of this report.

• Brand Name: ABUT HEX-LOCK 3.5MM IMP 5 .5 FLARE
• Common Device Name: DENTAL ABUTMENT SCREW
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16883037
• Report Number: 0002023141-2023-01268
• Device Sequence Number: 15154568
• Product Code: DZE
• UDI-Device Identifier: 00889024015180
• UDI-Public: (01)00889024015180(17)221231(10)63879646
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011028
• 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,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: HLA3/5
• Device Catalogue Number: HLA3/5
• Device Lot Number: 63879646
• 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: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/06/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 45 YR
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic