MAUDE Adverse Event Report: ZIMMER DENTAL HEAL COLLAR 3.5X4.5, 3MM; DENTAL HEAL COLLAR

Model Number HC343

Device Problem Component Misassembled (4004)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of the event unknown / not provided.Email address was not provided.

Event Description

It was reported that the healing collar hc343 - (gingiva former) could not be screwed and it could not be placed, the tip of the screw does not seat.

Manufacturer Narrative

Zimmer biomet complaint number cmp-0590768 the following sections have been updated: b4: date of this report b5: describe event or problem g4: date received by manufacturer g7: type of report, follow-up numbe h1: type of reportable event h2: follow up type h3: device evaluated by manufacturer h6: event problem and evaluation codes h10: additional narrative a heal collar 3.5x4.5, 3mm (hc343) was not returned.Since product has not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the devices was the same day.Pictures was provided by the customer.Seems to have slight thread damage.Device history record (dhr) review was completed for the subject lot number (2019060896).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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019060896) for similar event and no other complaint was identified.Based on the available information, device malfunction could not be verified and the reported event was non-verifiable.

Event Description

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

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).Three heal collar 3.5x4.5, 3mm (3 x hc343) were returned for investigation.Visual evaluation of the as returned products identified worn markings due to usage around body and the threads.Functional testing was performed for the returned products with an in-house stock device and one seated as intended.Two did not seat.Pre-existing patient factors, x-ray, tooth location are not relevant to the reported event.The length of the devices was the same day.Pictures were provided by the customer.Seems to have slight thread damage.Device history record (dhr) review was completed for the subject lot number (2019060896).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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number (2019060896) for similar event and no other complaint was identified.Based on the available information, device malfunction did not occur and the reported event is unconfirmed, however malfunction occurred with the other two and the reported event is confirmed.

Event Description

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

• Brand Name: HEAL COLLAR 3.5X4.5, 3MM
• Type of Device: DENTAL HEAL COLLAR
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10008943
• MDR Text Key: 190317735
• Report Number: 0002023141-2020-00820
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00889024014992
• UDI-Public: (01)00889024014992(17)240617(10)2019060896(241)HC343
• Combination Product (y/n): N
• PMA/PMN Number: K111852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2014
• Device Model Number: HC343
• Device Catalogue Number: HC343
• Device Lot Number: 2019060896
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1