MAUDE Adverse Event Report: DEPUY RAYNHAM 1219655 CANCELLOUS BONE SCREW 6.5X20MM; BONE SCREWS AND PINS : SCREWS

Catalog Number 117220000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hearing Loss (1882); Memory Loss/Impairment (1958); Pain (1994); Loss of Vision (2139)

Event Date 01/01/2018

Event Type  Injury  

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.

Event Description

(b)(6) communicated for complaint of his wife (b)(6) for jnj depuy product.Both hip replacement surgery and then revision surgery in max hospital.3rd surgery gridle surgery to remove depuy (jnj) defective.

Manufacturer Narrative

(b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.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).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.

• Brand Name: CANCELLOUS BONE SCREW 6.5X20MM
• Type of Device: BONE SCREWS AND PINS : SCREWS
• Manufacturer (Section D): DEPUY RAYNHAM 1219655; 325 paramount dr; raynham MA 02767 0988
• MDR Report Key: 8167482
• MDR Text Key: 130461885
• Report Number: 1818910-2018-78327
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10603295007609
• UDI-Public: 10603295007609
• Combination Product (y/n): N
• PMA/PMN Number: K970929
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 117220000
• Device Lot Number: EB9K34000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention