MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV LPS INSRT SM 32MM; KNEE TIBIAL INSERT

Model Number 1517-60-332

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

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 Description

It was reported that the outer package was opened to the field, lifted out of the clamshell with gloves hand.Surgeon noticed a silver spec on the package and it would not come off.Upon fully opening the foil, light could be seen coming through several holes in the foil.The implant was quarantined on the back corner of the table and the next size down implant was opened and implanted in the patient; this was not the optimal size for this patient.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: device associated with this report was received for examination.Examination of the returned device confirmed the complaint of damaged packaging.Upon initial review, damage was noted on the exterior of the unit carton.The inner tear pouch was reviewed and when held up to a light source, light was observed shining thru the holes noted in the complaint.The observed defects were reviewed and confirmed not as thru holes; however, as voids within a layer of the pouch construction.Since these are voids in the packaging material and are not thru holes in packaging, the contents of the packaging remains sterile and was not compromised by the presence of the voids in the foil packaging material.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 : dhr) was reviewed and no manufacturing related issues or deviations were noted.Device history review: dhr) was reviewed and no manufacturing related issues or deviations were noted.

• Brand Name: ATTUNE REV LPS INSRT SM 32MM
• Type of Device: KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY IRELAND 9616671; loughbeg, ringaskiddy co.; cork ; EI
• Manufacturer Contact: kara ditty-bovard ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 6107428552
• MDR Report Key: 13342357
• MDR Text Key: 284368007
• Report Number: 1818910-2022-01551
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295490951
• UDI-Public: 10603295490951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1517-60-332
• Device Catalogue Number: 151760332
• Device Lot Number: J8950N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ATTUNE REV LPS INSRT SM 29MM; ATTUNE REV LPS INSRT SM 32MM