MAUDE Adverse Event Report: BIOMET 3I CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 5.0MM(P) X 6MM(H); HEALING COVER

Model Number	IMHA356
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).Patient weight unknown / not provided.
Event or Problem Description
It was reported that there was a fracture of healing cap on implant.Referring dentist placed the healing cap after taking the impression but found the healing cap jammed/ then broke off, hours been spent trying to retrieve the broken screw portion, it appears to have cross threaded, cold welded within implant, removal and replacement.Tooth site # 8.
Additional Manufacturer Narrative
One certain® ep® healing abutment (imha356) and one 3i t3® tapered implant (bopt4311) were returned for investigation.Visual evaluation of the as returned products identified fracture across the abutment screw threads.Additionally, screw fragment was identified inside the implant; it was reported that hours had been spent to retrieve the broken screw portion which appeared to be cold welded within the implant.There was bone residue around the external threads of the implant which were damaged possibly during removal.Damage observed on returned implants due to trephine removal is not considered a malfunction or failure of the device.Zimmer biomet is not responsible for any damage caused by the clinician's removal of the device.Functional testing could not be performed due to the nature of the devices and event.Pre-existing condition noted on the per was low bone density ¿ type iii.The devices had been placed on tooth # 11 (fdi) for approximately 1 year.X-ray or picture images were provided.Appropriate documentation was reviewed.Dhr review for the lots (2019051747 & 1233156) 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.Lots were inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot numbers (2019051747 & 1233156) for similar events and no other complaint was identified.Based on the available information, device malfunction did occur and the reported event was confirmed.The following sections have been updated: b4: date of this report d9: device availability g3: date received by manufacturer g6: checked "follow-up" h2: checked follow-up type h3: changed "no" to "yes" h6: entered evaluation codes h10: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN® EP® HEALING ABUTMENT 3.4MM(D) X 5.0MM(P) X 6MM(H)
• Common Device Name: HEALING COVER
• 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: 12264118
• Report Number: 0001038806-2021-01421
• Device Sequence Number: 17293129
• Product Code: NHA
• UDI-Device Identifier: 00844868025726
• UDI-Public: (01)00844868025726(17)241111(10)1233156
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K072642
• 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,Company Representative
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• Device Model Number: IMHA356
• Device Catalogue Number: IMHA356
• Device Lot Number: 1233156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• 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: 07/14/2021
• Supplement Date Received by Manufacturer: 12/31/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male