MAUDE Adverse Event Report: BIOMET 3I CERTAIN STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H); DENTAL HEALING ABUTMENT

Model Number	ISHA44
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
Customer reported that the healing abutment would not seat down all the way in the implant.It was about 2mm sitting out of the implant.Doctor was able to complete the procedure with another healing abutment.
Additional Manufacturer Narrative
This report is being submitted to relay additional information.The following sections are being reported: b4: date of this report was updated.G3: date received by manufacturer was updated.G6: type of report was updated.H2: type of follow up was updated.H3: device evaluated by manufacturer was updated.H6: component code was added: 4755.H6: tyoe of investigation codes were added: 10, 4109, 3331, 4110 and 4111.H6: investigation findings code was added: 213.H6: investigation conclusions code was added: 67 and 4310.H10: narrative/data was updated.The product was returned and the reported event was unconfirmed following functional testing.Based on the evaluation, device malfunction has not occurred.Additionally, 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 actionable trends or corrective actions for the reported event or device.Zimmer biomet 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 zimmer biomet.Dhr review for the lots (1243390) had revealed no deviations nor non-conformances which could have caused or contributed to the reported event.Complaint history review was performed for the reported lot number (1243390) for similar events (complaint category keywords: does not seat) and no other complaints were identified.Functional testing was performed with an in-house implant.The device was able to seat onto the implant as normal.Therefore, the reported event couldn't be recreated.The complaint is related to the functional performance of the device.A definitive root cause could not be determined.However, those probable causes are not applicable to this investigation since device malfunction did not occur and the reported event was unconfirmed following functional testing.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 or Problem Description
No additional event information at the time of this report.

• Brand Name: CERTAIN STRAIGHT HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 4MM(H)
• Common Device Name: DENTAL HEALING ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11782647
• Report Number: 0001038806-2021-00750
• Device Sequence Number: 14336456
• Product Code: NHA
• UDI-Device Identifier: 00844868007883
• UDI-Public: (01)00844868007883(17)260228(10)1243390
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: ISHA44
• Device Catalogue Number: ISHA44
• Device Lot Number: 1243390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1