MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS RP INSRT SZ 8 10MM; ATTUNE IMPLANT : KNEE TIBIAL INSERT

Catalog Number	151650810
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that an item was received that came in with the plastic wrapping damaged.
Event or Problem Description
Additional information received stated: when we received the item the plastic cover on the outside of the box was torn.
Additional Manufacturer Narrative
Product complaint # (b)(4).D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.H11 additional narrative: added: b5, d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint #(b)(4).Investigation summary: according to the information received, ¿it was reported that an item was received on this order that came in with the plastic wrapping damaged¿.The product and photos of the reported condition (05_jul_2024_09_22_23_10771 and 02_jul_2024_15_51_13_22854) returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device and attachments.Visual analysis of the returned sample revealed that the right side of the outer packaging was found damage.Additionally, the shrink-wrap plastic was torn at the bottom right.No other defects that could have contributed to the reported event were observed.The potential cause of the observed condition cannot be traced to a manufacturing issue.Once the product leaves depuy synthes control, it is unknown what environment conditions or human intervention or manipulation the packaged products are exposed to during that time.Therefore, the suspected cause is traced to transport/storage outside of depuy synthes control.A dimensional inspection and functional testing were not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the attune ps rp insert sz 8 10mm would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to transport/storage and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot: a search of the depuy nonconformance (nc) quality system found no nc¿s associated with this product/lot combination.Corrected: h3.

• Brand Name: ATTUNE PS RP INSRT SZ 8 10MM
• Common Device Name: ATTUNE IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 19690244
• Report Number: 1818910-2024-14743
• Device Sequence Number: 8027854
• Product Code: NJL
• UDI-Device Identifier: 10603295052883
• UDI-Public: (01)10603295052883(10)4386296
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2024

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 Catalogue Number: 151650810
• Device Lot Number: 4386296
• 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: 07/02/2024
• Supplement Date Received by Manufacturer: 08/05/2024; 08/21/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/06/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown