MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 9 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS

Model Number	2545-00-709
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the posterior condyle broke off when the trial was impacted.
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information, which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained, that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was returned for analysis.Visual inspection of the physical device confirms initial complaint, the posterior condyle broke off.Additionally, discoloration condition was observed on the part and color indicator is slightly fading in one of its corners.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot (b)(4).Pi-(b)(4).Bfarm dhr review request: product description: attune cr fem trial sz 9 rt.Product code: 254500709.Lot number: mvmbnk870.1) quantity manufactured: (b)(4).2) date of manufacture: 07/2013.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a (reusable instrument).5) ifu reference: ifu-0902-00-836 rev.B.Device history review: a manufacturing record evaluation was performed for the finished device (product code 254500709/lot mvmbnk870) product and lot numbers, and no non-conformances were identified.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : the device associated with this report was returned for analysis.Visual inspection of the physical device confirms initial complaint, the posterior condyle broke off.Additionally, discoloration condition was observed on the part and color indicator is slightly fading in one of its corner.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.Device history lot : (b)(4).(b)(6).Bfarm dhr review request: product description: attune cr fem trial sz 9 rt.Product code: 254500709.Lot number: mvmbnk870.1) quantity manufactured: (b)(4).2) date of manufacture: 07/2013.3) any anomalies or deviations identified in dhr: none.4) expiry date: n/a (reusable instrument).5) ifu reference: ifu-0902-00-836 rev.B.Device history review : a manufacturing record evaluation was performed for the finished device (product code 254500709/lot mvmbnk870) product and lot numbers, and no non-conformances were identified.

• Brand Name: ATTUNE CR FEM TRIAL SZ 9 RT
• Common Device Name: ATTUNE INSTRUMENTS : FEMORAL TRIALS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13720786
• Report Number: 1818910-2022-04437
• Device Sequence Number: 4624197
• Product Code: HWT
• UDI-Device Identifier: 10603295133810
• UDI-Public: 10603295133810
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2022

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: 2545-00-709
• Device Catalogue Number: 254500709
• Device Lot Number: MVMBNK870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 04/01/2022; 05/25/2022; 06/27/2022
• Initial Report FDA Received Date: 03/10/2022
• Supplement Report FDA Received Date: 04/04/2022; 05/26/2022; 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2013
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown