MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FB INSRT SZ 7 6MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number 151640706

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2019

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

Found hair immediately after opening the implant box.

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.Investigation summary : examination of the returned device confirms the reported event.Product problem has not been identified.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.A complaint was received regarding an attune ps fb insrt sz 7 6mm stating: "found hair immediately after opening the implant box." another size of insert was chosen.No patient consequence was reported.A photograph was provided: review of the attached photograph identified a sterility pouch containing a poly bearing with a black hair showing over the products.It cannot be determined whether the hair was inside or outside of the sterile field.The product was returned to the company for investigation.The manufacturing site, raynham, performed the evaluation of the returned part and packaging.Their full report can be found in the pc-attachments.The main findings are as follow: date of manufacture of batch 579230 was 15 oct 2014.The unit carton, ifu, patient id labels, and product were returned.It is noted the implant was returned in a primary pouch that was unsealed.No secondary packaging materials were returned.There was a hair found within the unsealed pouch the product was returned in.It is noted that clean streams are used in the clean room as per mps ¿ 101838 machined products packaging process specification rev 30 and mps-ps65048 rev v, the revisions released at the time of manufacture of lot 579230, to ensure no foreign matter is present on primary or inner packaging materials.Given the state of the returned component, the source of the hair cannot be confirmed.A device history record review (dhr/traveler) was conducted for batch 579230.Per the traveler for batch (579230), the packaging and visual inspections were completed successfully.An internal product non-conformance search was conducted to understand if there were any internal non-conformances documented as related to the cosmetic appearance of packaging dating back to 2014 within the final packaging areas (machined and cast product clean rooms).No internal non-conformances were identified as related to the presence of foreign material on packaging material post packaging.A complaint search was conducted and one other related complaint was identified; however, the date of manufacture between that complaint and the current complaint was approximately 4 years, and as such, no trend has been detected.Given the above, a manufacturing issue could not be confirmed as the source of this non-conformance cannot be identified.Thus, the root cause of the reported defect is undetermined.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.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.

• Brand Name: ATTUNE PS FB INSRT SZ 7 6MM
• Type of Device: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork
• MDR Report Key: 8285698
• MDR Text Key: 134362225
• Report Number: 1818910-2019-82662
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295050216
• UDI-Public: 10603295050216
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 151640706
• Device Lot Number: 579230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Date Manufacturer Received: 03/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1