MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATT TIB PREP PLUS-IMPACT; INSTRUMENT CASES

Model Number	2545-01-715
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.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 attune primary tibial prep tray zzinnzk0857 is leaving residue from the lining of the metal tray on their instruments.
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.
Event or Problem Description
Additional information received: a.Request the cleaning and sterilization parameters used and ask if the cleaning and sterilization section of the ifu associated with the device was followed.? as per hospital policy and procedure, we use automated machine to wash most of our instruments per manufacturer instruction, instrument after being use goes to decontamination are for washing, we take instrument out of the tray for cleaning as needed before loading to automated machine wash, after the cycle instrument is either dry in the drying cabinet or by the use of airgun and check for cleanliness and damage before being wrap and sterilize.I have attached a information and the material compatibility the chemical we use for our automated machine.
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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this complaint was not returned.Photo evidence provided was reviewed.Based on the photo provided, it appears that some of the anodized coating on metal tray has deteriorated in some areas.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Investigation summary = > the device associated with this complaint was not returned.Photo evidence provided was reviewed.Based on the photo provided, it appears that some of the anodized coating on metal tray has deteriorated in some areas.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot = > a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary the device associated with this complaint was not returned.Photo evidence provided was reviewed.Based on the photo provided, it appears that some of the anodized coating on metal tray has deteriorated in some areas.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Drawing/specifications reviewed: drawing: n/a specification review was not performed since it was not applicable to the complaint condition.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Device history lot a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.,the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation mre was not performed.

• Brand Name: ATT TIB PREP PLUS-IMPACT
• Common Device Name: INSTRUMENT CASES
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 14802951
• Report Number: 1818910-2022-11759
• Device Sequence Number: 4677320
• Product Code: FSM
• UDI-Device Identifier: 10603295452478
• UDI-Public: 10603295452478
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Followup
• Report Date (Section B): 06/24/2022

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: 2545-01-715
• Device Catalogue Number: 254501715
• 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: 06/16/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 09/13/2022; 09/28/2022; 10/19/2022; 11/15/2022
• Initial Report FDA Received Date: 06/24/2022
• Supplement Report FDA Received Date: 07/04/2022; 09/13/2022; 09/29/2022; 10/20/2022; 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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