MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US MOD ENDO TOP TRAY; HIP INSTRUMENTS : INSTRUMENT CASES

Catalog Number 205511506

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/01/2022

Event Type  malfunction  

Event Description

It was reported that in review, a metal container full of blood is observed, which is of poor visual appearance, it is found of all norms and measures of bio-security; likewise, it is unknown source of body fluid origin.The container arrived for the patient, but the patient was never surgically operated on for health reasons, since he was admitted to the icu, the equipment was not in use and presented the novelty reported by the head of the department.The withdrawal was attempted 2 times but the institution denies the withdrawal as they claim to expect the patient to improve and have other johnson-authorized patients with hip fractures who can be intervened with the same devices.

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.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).Investigation summary: based on the visual analysis of the provided photographic evidence, it could be observed debris on the metal tray which appears to be blood.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.Device history lot: a manufacturing records evaluation (mre) was not performed as no lot number was provided for this device.H10 additional narrative: added: a1, a3.

• Brand Name: MOD ENDO TOP TRAY
• Type of Device: HIP INSTRUMENTS : INSTRUMENT CASES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 15446346
• MDR Text Key: 305265974
• Report Number: 1818910-2022-18198
• Device Sequence Number: 1
• Product Code: FSM
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205511506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male