MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PIN TRL LNR NEUT 48ODX32ID; HIP INSTRUMENTS : ACETABULAR TRIALS

Model Number	2218-32-048
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that mdr reached out letting me know of a green residue building on the acetabular trial liners.
Additional Manufacturer Narrative
(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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: no device associated with this report was received for examination.The investigation could not verify or draw any conclusions about the root cause of the reported event without the device to examine.Photo evidence provided shows only one device and it cannot provide evidence that indicates the other devices condition mentioned on this complaint.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 worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.
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
Cleaning protocol received from the hospital: the customer stated that: when the trays arrive in decontamination they are soaked in the enzymatic solution for 5 minutes and are then manually cleaned by an mdrt.After that, they go into our ultrasonics for 10 minutes.When they come out of the ultrasonic, we put them through our automated instrument washers.Once the trays come out of the washers on our "clean" side, we dry the contents, check them for soil, assemble as necessary and then they go into our autoclave on the standard cycle of 4min at 270 degrees f.The enzymatic solution we use in the soak and manual clean step is a steris product called valsure enzymatic cleaner.We mix it at 1/2oz valsure to 1 gallon of water.The other products we use are automated washers.They are all steris products.We use prolystica enzymatic cleaner, prolystica neutral detergent and prolystica lubricant non-silicone.

• Brand Name: PIN TRL LNR NEUT 48ODX32ID
• Common Device Name: HIP INSTRUMENTS : ACETABULAR TRIALS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 15615746
• Report Number: 1818910-2022-20586
• Device Sequence Number: 7941875
• Product Code: HWT
• UDI-Device Identifier: 10603295100706
• UDI-Public: 10603295100706
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 10/17/2022

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: 2218-32-048
• Device Catalogue Number: 221832048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2022
• Supplement Date Received by Manufacturer: 12/02/2022; 12/06/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 12/05/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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