MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X3.5, 3MM; HEALING COLLAR

Catalog Number HC333

Device Problem Positioning Failure (1158)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Age: not provided.Patient weight: not provided.Device not returned.

Event Description

It was reported that healing collar could not be screwed into the implant.Another healing collar held at the dental office was placed.No impact to the patient reported.Tooth location 28.

Event Description

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

Manufacturer Narrative

A heal collar 3.5x3.5, 3mm (hc333) was returned for investigation.Visual inspection of the as returned product identified worn markings due to usage and slight damage to the threads.Also, an associated product tsvmh11 has not been returned.However, this item is listed as associated item only and did not cause or contribute to the event.No further investigation will be conducted.Functional testing was performed for the returned product with an in-house stock device engages and seats 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.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (63251545).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 was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (63251545) for similar event and no other complaint was identified.March post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction (slight damage threads) did occur; however, the reported event (does not seat) was unconfirmed.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause determined from the investigation is the clinician does not follow the recommended protocol for product placement and final seating.No further investigation and no immediate capa/hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.The following sections have been updated: b4: date of this report d4: unique identifier (udi) number d4: expiration date g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: device evaluated by manufacturer h6: entered evaluation codes h10: added manufacturer narrative.

• Brand Name: HEAL COLLAR 3.5X3.5, 3MM
• Type of Device: HEALING COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11283432
• MDR Text Key: 230483022
• Report Number: 0002023141-2021-00297
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: HC333
• Device Lot Number: 63251545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1