MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MBT REV TIBIAL BROACH 29 MM; KNEE INSTRUMENT : BROACHES

Catalog Number	217863109
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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
Rev.G) for instruments of this system as there is a rubber-o-ring in the instrument so that the trial stem will have a tight fit.Because of this the instrument is difficult to clean.The given ref is an example.No surgery delay, no adverse consequences for patient reported.
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: the complaint was received into the company with the following comment: customer is requesting a reprocessing instruction (in addition to ifu-0902-00-836 rev.G) for instruments of this system as there is a rubber-o-ring in the instrument so that the trial stem will have a tight fit.Because of this the instrument is difficult to clean.The given ref is an example.No surgery delay, no adverse consequences for patient reported.The request was forwarded on to our research & design team for their comments.The r & d teams response was as follows: the reprocessing instructions for the mbt revision tibial broach are ifu-0902-00-836 rev g.Within the ifu, it is stated that if areas are difficult to inspect visually, check for blood by immersing or flushing the instrument in a 3% hydrogen peroxide solution.If bubbling is observed, blood is present.Rinse instruments for a minimum of 1 minute with warm, 30°c ¿ 40°c (85°f ¿ 104°f), tap water after using hydrogen peroxide solution.If soil is still present, re-clean the instrument.The mbt revision tibial broach has completed a cleaning validation to validate that this instrument can be cleaned in accordance with the ifu.This validation includes the challenging feature of the o-ring on the internal surface of the device.No information received with this individual complaint indicated that a broader investigation or corrective action was necessary.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: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: MBT REV TIBIAL BROACH 29 MM
• Common Device Name: KNEE INSTRUMENT : BROACHES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8475931
• Report Number: 1818910-2019-89444
• Device Sequence Number: 19211326
• Product Code: HTQ
• UDI-Device Identifier: 10603295096078
• UDI-Public: 10603295096078
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 217863109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 06/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1