MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. FOUNDATION HIP INSTRUMENT; OFFSET CUP IMPACTOR, MIS T8143

Catalog Number 803-11-103

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2016

Event Type  malfunction  

Event Description

Primary surgery/instrument failure -due to the inserter stripping out of the cup; the surgeon removed the cup insert and replaced.

Manufacturer Narrative

The reason for this complaint was to report that the inserter stripped out of the cup and the surgeon removed the cup insert and replaced it.The healthcare professional indicated there was a significant adverse event to the patient.There was a 15 minute delay in surgery and another suitable device was available for use.The revision surgery was completed as intended.The device has not made available to djo surgical for examination.The lot number or revision level were not reported, therefore this instrument could not be linked to a specific device history record (dhr) or the actual date of manufacture could not be determined with confidence.A review of the product complaint report history showed previous complaints but there were no indications that patients were at risk, or that this instrument has a design or material deficiency.Summary of complaints: (b)(4) functional, (b)(4) dull/worn, (b)(4) locking mechanism damaged, (b)(4) threads damaged/galled, (b)(4) missing feature, (b)(4) missing component, (b)(4) broke/cracked/damaged, (b)(4) hardware missing/lost.The root cause for this event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.Surgical instruments condition can be determined while being used for its intended purpose.The replacement of surgical instruments due to normal wear and tear does not indicate a product deficiency, failure or issue.No further action is deemed necessary at this time.

• Brand Name: FOUNDATION HIP INSTRUMENT
• Type of Device: OFFSET CUP IMPACTOR, MIS T8143
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• Manufacturer Contact: teffany hutto ; 9800 metric blvd.; austin, TX 78758-5445 ; 5128346255
• MDR Report Key: 5466618
• MDR Text Key: 39579556
• Report Number: 1644408-2016-00071
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

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: 803-11-103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2016
• Initial Date FDA Received: 02/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/11/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR