MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB TIB BASE SZ 4 CEM; KNEE TIBIAL TRAY

Model Number 1506-70-004

Device Problems Off-Label Use (1494); Tear, Rip or Hole in Device Packaging (2385); Difficult to Open or Remove Packaging Material (2922); Device Contaminated During Manufacture or Shipping (2969)

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

Event Date 01/20/2022

Event Type  malfunction  

Event Description

Customer found inner and outer plastic packaging stuck together.The packaging was malformed after sterilization.The products was not opened with sterile technique but the surgeon elected to utilize the implant.No reported surgical delay or patient harms.

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.

Manufacturer Narrative

Product complaint (b)(4).This product is being reported based on the potential for compromised sterility, though not confirmed at this time.The package was (opened in a sterile field/has a double barrier of sterile protection in which the outer barrier remained sealed).If further information is received regarding the event, a follow-up report will be provided at that time.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.H10.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.Visual examination of the provided photographic evidence denoted that the inner and outer blister of the packaging was melted/deformed.On the provided evidence, the tyvek lid was no lo longer attached to the blister seal.Since it is not possible to determine whether the lid was removed before or after the product was received by the costumer, sterility cannot be definitively confirmed.Based on provided evidence, it cannot be observed any condition on blister's seal and/or tyvek lid which denoted any difficulty to open the package.Since damages on the blister were observed before implantation, indications were not followed as specified.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: product code 150670004, work order (b)(4) was manufactured on 15 oct 2021.Total of (b)(4) were manufactured to specification.There were no deviations associated with this lot.There was no material reprocessing reports (mrr) associated with this lot.Device history review: a manufacturing record evaluation was performed for the finished device [lot/serial] number, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: ATTUNE FB TIB BASE SZ 4 CEM
• Type of Device: KNEE TIBIAL TRAY
• 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: 13711786
• MDR Text Key: 286874113
• Report Number: 1818910-2022-04342
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 10603295492061
• UDI-Public: 10603295492061
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K170806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1506-70-004
• Device Catalogue Number: 150670004
• Device Lot Number: 9877749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female