MAUDE Adverse Event Report: BIOMET 3I UNK BIOMET SCREW; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/20/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).Weight unknown / not provided.Brand name unknown / not provided.Catalog and lot number unknown / not provided.Pma/510(k) number not available.Device manufacture date not available.

Event Description

It was reported that there was a broken screw inside the implant at tooth location #10 that was unable to be removed.The implant had to be removed.

Manufacturer Narrative

This report is being submitted to relay corrected data and additional information.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H6: component code was added: 4755.H6: investigation type codes were added: 4111 and 4109.H6: investigation findings code was added: 3252.H6: investigation conclusions codes were added: 4307.H10: narrative/data was updated.The product was returned for investigation.The reported event is confirmed following inspection and evaluation.Based on the evaluation, the device malfunction has occurred.However, there is no existing nonconformance/capa/hhe/d/ie/product holds against the reported device that could cause or contribute to the reported event.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the products were likely within specifications and likely conforming when they left zimmer biomet.Dhr review and complaint history review could not be performed, as the lot number associated with the reported unk screw product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.No complaint history review could be performed without relevant lot and item information unk lb screw.The reported event could not be recreated due to the nature of the dental device and event and the complaint is related to the functional performance of the device.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 are patient factors/para-functional habits over the length of the implantation period.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.

Event Description

No additional event information at the time of this report.

• Brand Name: UNK BIOMET SCREW
• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11143044
• MDR Text Key: 226009159
• Report Number: 0001038806-2021-00041
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BNPS4315-ZIMMER BIOMET IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR