MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 5MM; ABUTMENT

Model Number	HC335
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number: (b)(4).Patient id not provided.Patient weight not provided.
Event or Problem Description
It was reported that it is impossible to screw the healing collar into the implant.Procedure was not completed with another item.
Event or Problem Description
There is no update to the original complaint description provided.
Additional Manufacturer Narrative
One heal collar 3.5x3.5, 5mm (hc335) was returned for investigation.Visual evaluation of the as returned product identified damage around the threads.Functional testing was performed using an applicable in-house implant.The device could not be threaded fully into the implant due to thread damage.Pre-existing condition noted in the per was low bone density ¿ type iii.The device was intended for tooth # 45.X-ray & picture evaluation: x-ray or picture images were not provided, and no other information was provided.Review of appropriate documentation: documents reviewed: instructions for use ¿ zimmer dental healing collars, healing screws, surgical cover screws, temporary gingival cuffs, and temporary abutments for use with zimmer dental implant systems, ifu9658 rev 2-10/19.Information identified: indications and warnings.Per the applicable ifu, improper techniques and overloading may lead to device failure.Dhr review: dhr review for the lot (2019021121) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019021121) for similar events (complaint category keywords: functional: other (damaged threads; does not seat)) and no other complaint was identified.Post market trending review: august post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, healing collar malfunction did occur and the reported event was confirmed.

• Brand Name: HEAL COLLAR 3.5X3.5, 5MM
• 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: 14461920
• Report Number: 0002023141-2022-01261
• Device Sequence Number: 5175744
• Product Code: NHA
• UDI-Device Identifier: 00889024014985
• UDI-Public: (01)00889024014985(17)240218(10)2019021121
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111852
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2022

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 Expiration Date: 02/18/2024
• Device Model Number: HC335
• Device Catalogue Number: HC335
• Device Lot Number: 2019021121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2022
• 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: 05/09/2022
• Supplement Date Received by Manufacturer: 10/04/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2019
• 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: 65 YR
• Patient Sex: Female