MAUDE Adverse Event Report: ZIMMER DENTAL SCR REPLACEMENT SCR-V 20 DEG ABUT INT HEX; DENTAL SCREW

Model Number	AH20S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Pma/510(k): k011028 and k013227.
Event or Problem Description
It was reported that screw fractured and was removed.Implant is in good condition.
Event or Problem Description
No additional or corrected information to report.
Additional Manufacturer Narrative
The reported device was received for evaluation.The reported condition of a fractured screw was confirmed.Visual evaluation of the as returned product identified significant signs of wear around the threads and fracture at the screw head.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.A device history record (dhr) review was completed for the reported device lot.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance, which could have caused or contributed to the reported event was noted as part of the dhr.A complaint history review was completed for the reported device lot for similar event and no other complaint was identified.A definitive root cause for the reported event could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: SCR REPLACEMENT SCR-V 20 DEG ABUT INT HEX
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 9664407
• Report Number: 0002023141-2020-00222
• Device Sequence Number: 19530883
• Product Code: DZE
• UDI-Device Identifier: 00889024013742
• UDI-Public: (01)00889024013742(17)230704(10)2018062617(241)AH20S
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2023
• Device Model Number: AH20S
• Device Catalogue Number: AH20S
• Device Lot Number: 2018062617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 04/14/2020
• Initial Report FDA Received Date: 02/04/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR