MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SIGTIBCEMSTM 13X30 1.5/2/2.5/3; UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS

Catalog Number	866401
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is a damaged product.Doi: unknown, dor: unknown, affected side: unknown knee.
Additional Manufacturer Narrative
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.Additional narrative: 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.According to the information received, it was reported that the rep still have a damaged product.A manufacturing record evaluation were performed; no non-conformances / manufacturing irregularities were identified.1) ordered quantity: (b)(4) pcs.2) date of manufacture: 18-apr-2025.3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 31-mar-2035.5) ifu reference: ifu-0902-00-252.After searching "d25040399" in etq, no record is displayed.After searching the product description in nr list exported from the etq system, all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching " d25040399" in sap by zqmr1023, no internal lock record is displayed.Hereby drawing a conclusion that no non-conformances were identified for this batch of products.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.Device history lot: a manufacturing record evaluation were performed; no non-conformances / manufacturing irregularities were identified.1) ordered quantity: (b)(4) pcs.2) date of manufacture: 18-apr-2025.3) any anomalies or deviations identified in dhr: no nonconformities were identified.4) expiry date: 31-mar-2035.5) ifu reference: ifu-0902-00-252.After searching "d25040399" in etq, no record is displayed.After searching the product description in nr list exported from the etq system, all results have been reviewed, no case even similar to the issue described in this complaint is identified.After searching " d25040399" in sap by zqmr1023, no internal lock record is displayed.Hereby drawing a conclusion that no non-conformances were identified for this batch of products.

• Brand Name: SIGTIBCEMSTM 13X30 1.5/2/2.5/3
• Common Device Name: UNIVERSAL KNEE STEMS AND SLEEVES : KNEE STEMS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22630334
• Report Number: 1818910-2025-13017
• Device Sequence Number: 7994362
• Product Code: JWH
• UDI-Device Identifier: 10603295216896
• UDI-Public: (01)10603295216896(17)350331(10)D25040399
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K882234
• 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

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: 866401
• Device Lot Number: D25040399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2025
• 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