MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HARDINGE FEM CEMENT RESTR; CEMENT CENTRALIZER/PLUG

Catalog Number 963203000

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); Insufficient Information (4580)

Event Date 02/14/2024

Event Type  malfunction  

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 Description

It was reported that the setting instrument for the medullary canal stopper broke off when it was unscrewed.No force was used.The approximately 6 cm long fragment could not be removed and had to remain in the patient.

Event Description

Additional information was received and stated that the operation was delayed by half an hour.They could not remove the broken part and pushed it into the medullary space distal.The patient now has an additional foreign body and the operation and anesthesia took longer.It was also reported that the instrument broke into 2 parts.

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.H10 additional narrative: added: b5, d4 (lot), d9 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Corrected: h3.

• Brand Name: HARDINGE FEM CEMENT RESTR
• Type of Device: CEMENT CENTRALIZER/PLUG
• Manufacturer (Section D): DEPUY INTERNATIONAL LTD - 8010379; st. anthony's road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 18799910
• MDR Text Key: 336525899
• Report Number: 1818910-2024-03944
• Device Sequence Number: 1
• Product Code: JDK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: OUS
• 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
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 963203000
• Device Lot Number: 2328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1