MAUDE Adverse Event Report: ZIMMER DENTAL ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE; ABUTMENT

Model Number	HLA4/5
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the abutment hla4/5 and screw was tightened, the surgical screwdriver cannot be removed.It could be replaced with a new abutment of the same model.
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight: patient weight not provided.Pma/510k: additional 510(k) numbers are k013227 and k953101.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One (1) abut hex-lock 4.5mm imp 5.5 flare (hla4/5) was returned for investigation.Visual evaluation of the as returned product identified no damage/malfunction.Functional testing to recreate the reported event with an in-house driver, found the hla4/5 engaged/disengaged as intended.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the device usage is unknown.The customer did not provide any pictures.Information identified: warnings, precautions dhr review: dhr review was completed for the subject lot numbers (2019050536).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: a complaint history review by item numbers was conducted for the (hla4/5) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported device related to the reported event.Review completed utilizing keywords: does not disengage/release.Post market trend review: march post market trending was reviewed and there were no actionable events or corrective actions for the reported event (does not disengage/release) or product (hla4/5).No actionable items have been triggered that will affect complaint handling on our end for this month.Based on the available information, device malfunction did not occur and the reported event was non-verifiable.Sections updated: b4: date of this report.D9: device availability and product return date.G3: date investigation results were received.G6: type of report and follow up number.H2: follow up type.H3: device evaluated.H6: adverse event problem codes.H10: manufacturer's narrative.

• Brand Name: ABUT HEX-LOCK 4.5MM IMP 5 .5 FLARE
• Common Device Name: ABUTMENT
• 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: 12844254
• Report Number: 0002023141-2021-03349
• Device Sequence Number: 14540737
• Product Code: DZE
• UDI-Device Identifier: 00889024015210
• UDI-Public: (01)00889024015210(17)240510(10)2019050536(241)HLA4/5
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2022

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: 05/10/2024
• Device Model Number: HLA4/5
• Device Catalogue Number: HLA4/5
• Device Lot Number: 2019050536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female