MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TANDEM STR THREADED HNDLE; PRSTHSIS,HIP,SMI-CONSTRIND,MTL/POLYMR,CMNTED

Catalog Number	71362804
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery handle broke down the middle on insertion of trial heads.No harm to the patient or staff.Nothing got into the patient.No procedural delay because a smith and nephew back up was available.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection confirmed the handle is broken down the middle on insertion of trial heads and the other piece was returned.This device also has significant signs of wear/usage.The manufactured date for this device is 2004.A complaint history and dhr review not performed for this event, as no manufacturing, packaging or labelling defects were associated with the reported failure.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: TANDEM STR THREADED HNDLE
• Common Device Name: PRSTHSIS,HIP,SMI-CONSTRIND,MTL/POLYMR,CMNTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9280302
• Report Number: 1020279-2019-03882
• Device Sequence Number: 2183556
• Product Code: JDI
• UDI-Device Identifier: 03596010497994
• UDI-Public: 03596010497994
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71362804
• Device Lot Number: 04AM10538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1