MAUDE Adverse Event Report: BIOMET 3I CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)

Catalog Number ISHA43

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Weight unknown / not provided.Lot number unknown / not provided.Device not returned.

Event Description

It was reported that the abutment was found loose at the follow up appointment.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).An certain® gold-tite® hexed screw (item # isha43) 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 using the item #/ item # and lot # (dhr/ifu/rmf).Dhr review and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A complaint history review by item number was conducted for the (item # isha43) dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformance/capa/hhe/d/ie/product holds for the reported device related to the reported event.Therefore, based on the available information, device malfunction could not be verified and the reported event was non-verifiable.No further investigation or 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.

Event Description

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

• Brand Name: CERTAIN® STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 3MM(H)
• Type of Device: HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9213057
• MDR Text Key: 176263428
• Report Number: 0001038806-2019-01212
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ISHA43
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1