MAUDE Adverse Event Report: ZIMMER DENTAL TOOL HEX SST 1.25MM 22MM; DENTAL HEX DRIVER

Catalog Number HXL1.25

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).

Event Description

It was reported that the tip of the hex driver fractured while doctor was torquing down the implant during procedure.Doctor stopped using the driver and used another product.

Manufacturer Narrative

One tool hex sst 1.25mm 22mm (hxl1.25) was returned for investigation.Visual evaluation of the as returned product identified that the tip was twisted and fractured.Functional testing could not be performed since the device was fractured.Pre-existing patient conditions, tooth location, implantation period, x-ray images are irrelevant to this investigation.Dhr review could not be performed since the lot number associated to the item was not provided.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.A year-long complaint history review by item number (hxl1.25) was performed for similar events and four other complaints were identified.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did occur and the reported event was confirmed.The probable cause for the reported event is excessive torque applied during placement/seating due to improper surgical procedure or poor case planning.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 available at the time of this report.

Event Description

Additional information (device lot number) was provided.

Manufacturer Narrative

Customer provided device lot number 62613906.Product evaluation report was updated.Additional information provided below.Dhr review for the lot (62613906) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.All products were conforming at the time they left zimmer biomet.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the lot (62613906) for similar events and no other complaint was identified.The following sections have been updated: b4: date of this report.D4: lot number.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H4: manufacturer date.H10: added manufacturer narrative.

• Brand Name: TOOL HEX SST 1.25MM 22MM
• Type of Device: DENTAL HEX DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11020075
• MDR Text Key: 221816542
• Report Number: 0002023141-2020-02299
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

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
• Device Catalogue Number: HXL1.25
• Device Lot Number: 62613906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/16/2020
• Supplement Dates Manufacturer Received: 03/12/2021; 03/18/2021
• Supplement Dates FDA Received: 03/17/2021; 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1