MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS LTD BHR CAPSULOTOMY SCISSORS; PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING

Model Number 999907

Device Problems Sticking (1597); Failure to Cut (2587)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation in process.

Event Description

Scissors are sticking and not cutting properly.Case was not a revision, it was not delayed and the patient was not harmed.

• Brand Name: BHR CAPSULOTOMY SCISSORS
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/METAL, RESURFACING
• Manufacturer (Section D): SMITH & NEPHEW ORTHOPAEDICS LTD; 1 kingmaker court; gallows hill CV34 6WG; UK CV34 6WG
• Manufacturer (Section G): SMITH & NEPHEW ORTHOPAEDICS LTD; aurora house; spa park; leamington spa CV31 3HL; UK CV31 3HL
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau, FL 5001 ; SZ 5001
• MDR Report Key: 4959598
• MDR Text Key: 23392318
• Report Number: 3005477969-2015-00205
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 999907
• Device Catalogue Number: 999907
• Device Lot Number: 4195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2015
• 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