MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED

Catalog Number 71364006

Device Problems Detachment Of Device Component (1104); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that black handle of this device cracked in half during surgical procedure and broke off while malleting.Backup was available to no delay and the patient was not affected.

• Brand Name: T-HANDLE
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001 ; 0628320660
• MDR Report Key: 6043169
• MDR Text Key: 57924947
• Report Number: 1020279-2016-00803
• Device Sequence Number: 1
• Product Code: JDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 71364006
• Device Lot Number: 00708044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/20/2016
• 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: Reuse
• Patient Sequence Number: 1
• Patient Age: 64 YR