MAUDE Adverse Event Report: BIOMET 3I RIGHT ANGLE SLOTTED DRIVER TIP, 24MM; DENTAL DRIVER TIP

Model Number	RASD1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor indicated chipped tip, damaged.When removing the healing abutment, the driver tip was used.It was used for the first time, but the tip part was damaged with almost no torque applied.The operation has been postponed, but there is no health hazard.Tooth site # 29 (universal).
Additional Manufacturer Narrative
Zimvie complaint (b)(4).Item and lot number are not provided / unknown initial reporter¿s title is not provided / unknown.
Additional Manufacturer Narrative
This report is being submitted to report additional information.The following sections are being reported: d4: unique identifier (udi) number; d9: device availability; h2: if follow-up, what type; h3: device evaluated by manufacturer; h4: device manufacturer date; h6: type of investigation; h6: investigation findings; h6: investigation conclusions; h10: additional narratives/data.The product was returned, and the reported event was confirmed following visual evaluation.Based on the evaluation, device malfunction has occurred.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported event.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review for the lot had revealed no deviations or non-conformance's which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be determined.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.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.
Event or Problem Description
No additional or corrected information to report.

• Brand Name: RIGHT ANGLE SLOTTED DRIVER TIP, 24MM
• Common Device Name: DENTAL DRIVER TIP
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 15284994
• Report Number: 0001038806-2022-01310
• Device Sequence Number: 2328925
• Product Code: NDP
• UDI-Device Identifier: 00844868015215
• UDI-Public: (01)00844868015215(11)220617(10)1254653
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2023

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 Model Number: RASD1
• Device Catalogue Number: RASD1
• Device Lot Number: 1254653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 01/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL HEALING ABUTMENT
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 71 KG