MAUDE Adverse Event Report: BIOMET 3I DRILL EXTENDER

Catalog Number DE

Device Problem Separation Problem (4043)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided.Age and date of birth unknown / not provided.Patient sex unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Lot number unknown / not provided.

Event Description

It was reported that the shaft of the drill extension fractured and was swallowed.Endoscopy was performed to retrieve the drill.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).A drill extender head (item # de) was received for investigation.Visual inspection of the as returned product identified a fracture that has separated the head from its shaft, which was not returned functional testing to recreate the reported event could not be performed due to the nature of the device & event.Appropriate documentation was reviewed.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 # de) dating back to 12 months from now.The complaint history review revealed that there are no existing non conformance/capa/hhe/d/ie/product holds for the reported device related to the reported event.Therefore, based on the available information, device malfunction had occurred and the reported fracture event was confirmed.However, the reported swallowing event could not be verified with the available evidence 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 further event information is available at the time of this report.

• Brand Name: DRILL EXTENDER
• Type of Device: DRILL EXTENDER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9168195
• MDR Text Key: 176054925
• Report Number: 0001038806-2019-01159
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

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: DE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1