MAUDE Adverse Event Report: ZIMMER DENTAL RETAINING 2.5MM HEX DRIVE R SHORT; DRIVER

Catalog Number RH2.5

Device Problem Separation Failure (2547)

Patient Problem No Information (3190)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Event Description

It was reported that driver got stuck in the implant and as a result the implant needed to be removed.No injury to patient other than implant being removed.Tooth 22.No permanent impairment.

Event Description

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

Manufacturer Narrative

One impl tapered scr-v mtx 3.7mm 3.5mm 11.5mm (tsvb11) was returned for investigation.The reported rh2.5 driver was not returned for inspection.Visual inspection of the as returned product identified minimal signs of wear about the implant body and threads.No pre-existing conditions were noted on the per.The patient has moderate bone density.The reported product was located on tooth # 22 (universal) and removed the same day.The reported returned device was functionally tested and found to assemble, retain, and disengage as normal with a mating driver (functional testing).No malfunction was detected.The customer has not provided additional pictures or x-ray images of the product.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number 1236647.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.(rh2.5) 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.(tsvb11) complaint history review was performed for the reported lot number (1236647) for similar event and no other complaint was identified.(rh2.5) a complaint history review by item number was conducted for the rh2.5 dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/ie/product holds for the reported product.Based on the available information, device malfunction has not occurred and the reported event was non-verifiable without return of both devices and following functional testing of the returned implant.The following sections have been updated: b4: date of this report g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "yes" to "no" h6: entered evaluation codes h10: added manufacturer narrative h3 other text : device not returned.

• Brand Name: RETAINING 2.5MM HEX DRIVE R SHORT
• Type of Device: DRIVER
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11031903
• MDR Text Key: 222283171
• Report Number: 0002023141-2020-02334
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RH2.5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 04/13/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention