MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S/C TRIAL HANDLE ANGLED; HIP INSTRUMENTS : HANDLES

Catalog Number 205513000

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/21/2019

Event Type  malfunction  

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

Physician reported that products can`t be properly decontaminated from blood and tissues.After few decontamination session physician still couldn`t use product during surgery because some blood and tissue remain into product.To procedure completed physician used another one product the same type (brand new one).No consequences for the patient reported.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision of 21 cfr, part 803.The report may be based on the 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.Product complaint #: (b)(4).Investigation summary: the complaint cannot be confirmed as no devices were returned.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: S/C TRIAL HANDLE ANGLED
• Type of Device: HIP INSTRUMENTS : HANDLES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 8758097
• MDR Text Key: 150115100
• Report Number: 1818910-2019-97630
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10603295084488
• UDI-Public: 10603295084488
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 205513000
• Device Lot Number: PG278479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1