MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE TIBIA DRILL; ATTUNE INSTRUMENTS : DRILLS

Model Number	2545-00-125
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, the patient underwent the surgery via tka for oa with the reamer in question.During the reamer use, it was found that the colored lines of the reamer to confirm the reamer depth might be colored in the opposite direction from usual.The normal size of 3-5 lines was recognized as green and 6-8 lines as yellow, which was also described in the surgical technique.However, the line of the instrument used this time was reversed, and the 3-5 lines were yellow and the 6-8 lines were green.According to the surgeon, the depth to which the bone should be excavated is checked by the color of the line.If the color is opposite to that of the normal one, the bone may be cut off more than necessary, which may cause an accident.The surgery was completed successfully without any surgical delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).All medical device reports associated with the same/similar device(s) and labeling : incorrect were reviewed.It was determined labeling : incorrect has not caused or contributed to any deaths or serious injuries within the time period of (b)(6), 2020 ¿ (b)(6), 2023.In total, there have been zero serious injuries and zero deaths reports related to labeling : incorrect in the last 3.5 years.Based on the data, the likelihood of a death or serious injury occurring as a result of the failure is remote; therefore, labeling : incorrect associated with same/similar device(s) of this report will no longer be reported as a medical device report (mdr) unless the event results in a reportable event per 21 cfr 803.50.

• Brand Name: ATTUNE TIBIA DRILL
• Common Device Name: ATTUNE INSTRUMENTS : DRILLS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 12365951
• Report Number: 1818910-2021-18635
• Device Sequence Number: 11866798
• Product Code: HWE
• UDI-Device Identifier: 10603295427568
• UDI-Public: 10603295427568
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 08/25/2021

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 Model Number: 2545-00-125
• Device Catalogue Number: 254500125
• Device Lot Number: NG70658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2018
• 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