MAUDE Adverse Event Report: BIOMET 3I INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG

Catalog Number IIPDTUL

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Patient identifier is not provided / unknown.Patient age is not provided / unknown.Patient weight is not provided / unknown.Date of event is not provided / unknown.Lot number is not provided / unknown.Initial reporter¿s title is not provided / unknown.

Event Description

It is reported that the driver disengaged from the implant and the implant was dropped.They were able to complete the procedure with a different tool.

Manufacturer Narrative

Based on the evaluation, device malfunction for the driver has not occurred.Additionally, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or device.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 within specifications and conforming when they left zimmer biomet.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 prevent the distribution of non-conforming product is within specifications.A complaint history review by item number was conducted for the driver dating back to 12 months prior to the notification date.The complaint history review revealed that there are no existing non-conformance's/capa/hhe/d/ie/product holds for the reported device related to the reported event.Functional testing was performed using an in-house implant and the devices were able to engage, retain and disengage as normal.Therefore, the reported event could not be recreated.The complaint is related to the functional performance of the device.A definitive root cause could not be identified.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 additional or corrected information to report.

• Brand Name: INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG
• Type of Device: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 13062804
• MDR Text Key: 283488770
• Report Number: 0001038806-2021-02412
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

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
• Device Catalogue Number: IIPDTUL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 06/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose