MAUDE Adverse Event Report: BIOMET 3I; HANDPIECE

Device Problem Device Fell (4014)

Patient Problem No Information (3190)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Implant date unknown / not provided.Explant date unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported the implant dropped while attempting to removal from the vial.They stated the doctor dropped prior to insertion from handpiece attachment.The procedure was completed using another device.No injury to the patient as a result of the event.Tooth location not reported.

Event Description

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

Manufacturer Narrative

One imp,tsv,4.1mm,dual sel,ha (tsv4h11) was returned for investigation (image 1-4).Visual inspection of the as returned product identified signs of wear from use about the implant threads.The implant is noted not to have been used in a patient.Functional testing of the returned device notes that the square engagement outer drive feature functions as intended with a mating ratchet wrench (functional testing 1).Likewise, the internal hex drive feature of the implant and mount function as intended with a mating square engagement driver (functional testing 2-3).Appropriate documentation was reviewed.Dhr 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 could not be performed without relevant item and lot information.Based on the available information, device malfunction has not occurred and the reported event as it relates to the returned implant was unconfirmed following functional testing.Functionality of the handpiece driver could not be verified with the information provided.The following sections have been updated: g7: checked "follow-up"; h2: checked follow-up type; h3: changed "no" to "yes"; h6: entered evaluation codes.

• Type of Device: HANDPIECE
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10196762
• MDR Text Key: 196937010
• Report Number: 0001038806-2020-00887
• 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: 09/23/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 09/18/2020
• Supplement Dates FDA Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention