MAUDE Adverse Event Report: SMITH & NEPHEW, INC. REF THREADED HOLE COVER; REFLECTION 3 ACETABULAR SYSTEM

Catalog Number 71336500

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer indicated that there is no product/device to be returned for investigation analysis.

Event Description

It was reported during hip procedure, the hole cover went through the center hole and surgeon was unable to retrieve, therefore remained implanted with patient.

Manufacturer Narrative

The associated complaint devices were not returned for evaluation.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for listed part revealed prior complaints for the listed failure mode, and no prior complaints for the listed lot.The devices were manufactured in 2016.Based on this investigation, the need for corrective action is not indicated.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: REF THREADED HOLE COVER
• Type of Device: REFLECTION 3 ACETABULAR SYSTEM
• 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: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5836691
• MDR Text Key: 51758387
• Report Number: 1020279-2016-00589
• Device Sequence Number: 1
• Product Code: MBL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71336500
• Device Lot Number: 16BM03712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other