MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE REV TIB CEM CONICAL RMR; ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS

Catalog Number	250620103
Medical Device Problem Codes	Peeled/Delaminated (1454); Mechanical Jam (2983); Scratched Material (3020)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.
Event or Problem Description
It was reported that the blade of the tibial cemented conical reamer (p/n: 250620103) was caught in the sri attune stemable tibia tower (manufactured by ksi) and it was stuck and the fixed tibia plate was come off during tka surgery on (b)(6) 2019.The surgeon re-placed it and repeated the same process.However, the blade and tower were scraped, and the metal powder was appeared.Thus, the surgeon stopped using the instruments to prevent health damage to the patient.The surgery was completed within a 30 minutes surgical delay.There was no adverse consequence to the patient.It seemed to be an issue of accuracy of the tibia tower and the conical reamer.No further information is available.
Additional Manufacturer Narrative
(b)(4).Evaluation of the returned device confirms deformation to the reamer.Depuy considers the investigation closed at this time.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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: evaluation of the returned device confirms deformation to the reamer.Depuy considers the investigation closed at this time.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.

• Brand Name: ATTUNE REV TIB CEM CONICAL RMR
• Common Device Name: ATTUNE STEMMABLE TIBIA INSTRUMENTS : REAMERS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8492459
• Report Number: 1818910-2019-90124
• Device Sequence Number: 1471293
• Product Code: HTO
• UDI-Device Identifier: 10603295440567
• UDI-Public: 10603295440567
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/18/2019

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 Catalogue Number: 250620103
• Device Lot Number: NG64617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 03/18/2019
• Supplement Date Received by Manufacturer: 05/07/2019; 05/07/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 05/09/2019; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1