MAUDE Adverse Event Report: BIOMET 3I CERTAIN TITANIUM HEXED SCREW; DENTAL SCREW

Catalog Number IUNIHT

Device Problem Fracture (1260)

Patient Problems Irritation (1941); No Information (3190)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Age: not provided.Initial reporter fax number: not provided.Device was not returned.

Event Description

It was reported that abutment screw (iunihg) fractured within the implant during crown loading at tooth location 19.All fractured parts were removed and implant remains intact.Another abutment was placed.

Event Description

Additional information confirmed that patient experienced a irritation of its tongue after screw fracture.However, after the fracture screw was removed, patient did no refer any discomfort related to its tongue.

Manufacturer Narrative

Additional information confirmed that patient experienced a irritation of its tongue after screw fracture.However, after the fracture screw was removed, patient did no refer any discomfort related to its tongue.The following sections have been updated: a2: patient age.B4: date of this report, g4: date received by manufacturer, g7: checked "follow-up", h2: checked follow-up type , h6: patient evaluation codes updated.H10: added manufacturer narrative.

Manufacturer Narrative

A certain® gold-tite® hexed screw (iunihg) was not returned.Since product has not been returned, visual/functional evaluation could not be performed.The investigation has been performed based on the available information.No pre-existing conditions were noted on the per.The reported device was located on tooth # 36 and length of usage is unknown.Pictures or x-ray images were not provided.Dhr review was completed for the subject lot number (1186478).It was confirmed that all operations and inspections were executed as per the 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 (1186478) for a 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 could not be verified and the reported event was non-verifiable.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely cause for the reported event is customer error for torque applied during placement/seating exceeds the recommended value.The following sections have been updated: b4: date of this report, d4: unique identifier (udi) number, d4: expiration date, g4: date received by manufacturer, g7: checked "follow-up", h2: checked follow-up type, h4: manufacturer date, h6: entered evaluation codes, h10: added manufacturer narrative.

Event Description

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

Manufacturer Narrative

A certain® titanium hexed screw (iuniht) and certain® gingihue® 15° angled post 5mm(d) x 5mm(p) x 4mm(h) (ipap554g) were returned for investigation.Visual evaluation of the as returned products identified damage, possibly due to the removal process.Also, the abutment shows heavy modifications by the doctor.No fractures were identified.No pre-existing conditions were noted on the per.The reported devices was located on tooth # 36 but the length of usage is unknown.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) 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.June 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 did not occur and the reported event was unconfirmed.

Event Description

Additional information was received.Product was returned for investigation and device returned was identified to be iuniht lot unknown.It was initially reported that abutment screw was fractured and fractured screw parts and abutment were removed.Implant was indicated to be in good condition and that another abutment was placed.However, no fracture was identified in the returned device per device evaluation.

• Brand Name: CERTAIN TITANIUM HEXED SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9788240
• MDR Text Key: 182134519
• Report Number: 0001038806-2020-00466
• 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,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2020
• Device Catalogue Number: IUNIHT
• Device Lot Number: 1186478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 75