MAUDE Adverse Event Report: BIOMET 3I UNKNOWN PLACEMENT TOOL; DENTAL PLACEMENT TOOL

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Pma/510(k) number not available.Device location unknown.

Event Description

It was reported that the placement tool was stuck in the implant.

Event Description

No additional event information at the time of this report.

Manufacturer Narrative

This report is being submitted to relay device evaluation results 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.H3: device evaluated by manufacturer was updated.H6: component code was added: 4755.H6: investigation type codes were added: 4111 and 4114.H6: investigation findings code was added: 3221.H6: investigation conclusions codes were added: 4315.H10: narrative/data was updated.The reported event is non-verifiable without return of the unknown placement tool.Based on the evaluation, the device malfunction could not be verified for the unknown placement tool.There is no existing nonconformance/capa/hhe/d/ie/product holds against the reported product that did or 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 product was likely within specification and likely conforming when it left zimmer biomet.Dhr review could not be performed, as the lot number associated with the reported unknown placement tool is not available.Additionally, a complaint history review could not be performed without relevant item and lot information.The reported event could not be recreated without return of the unknown placement tool for testing.As per the risk management file, the potential causes for the reported event are related to customer error via tool usage, seating, and a possible lack of maintenance.A definitive root cause could not be identified.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.H3 other text : device not returned.

• Brand Name: UNKNOWN PLACEMENT TOOL
• Type of Device: DENTAL PLACEMENT TOOL
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11288017
• MDR Text Key: 230738946
• Report Number: 0001038806-2021-00192
• Device Sequence Number: 1
• Product Code: NDP
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 05/26/2021
• Supplement Dates FDA Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1