MAUDE Adverse Event Report: ENCORE MEDICAL L.P. HIP SURGICAL INSTRUMENT; HANDLE, FEMORAL STEM INSERTER

Catalog Number	803-00-015
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - during impaction of femoral hip implant, into the femoral canal, the tip of the inserter broke off.The implant was successfully inserted into the canal along with the broken tip inside the implant's threaded hole.
Additional Manufacturer Narrative
To date the inserter has not been returned for investigational review.It has been in excess of 49 days from the date created and the agency did indicate that the instrument would be returned for evaluation.When the reported even occurred the instrument may have been in service for 2.7 years.This event occurred during surgery near the patient.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended, there was no risk or adverse event reported and the instrument was inspected prior to surgery and was found to be acceptable.Instruments are subjected to heavy use/misuse/wear and care must be taken to avoid compromising their performance.A review of the device history record (dhr) revealed when released for use, met design and manufacturing requirements.A review of the complaint history indicates to date, 4 complaints have been reported against this lost number.Summary of complaints for the part number: 2 - functional, 2 - dull/worn, 1 - seized/galled, 44 - thread damaged/galled, 1 - dimensional concern, 3 - bent, 19 - broke/cracked/damaged, 1 - device cracked/broke, 1 - end of life, 32- blank.No further evaluation can be made for this event.This customer complaint will be closed.If the device is returned a complaint amendment will be initiated.The root cause for the initial problem cannot be determined with confidence as the instrument was not returned for investigational review.No containment of inventory required, material or design issues cannot be identified.

• Brand Name: HIP SURGICAL INSTRUMENT
• Common Device Name: HANDLE, FEMORAL STEM INSERTER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7862103
• Report Number: 1644408-2018-00856
• Device Sequence Number: 13956467
• Product Code: LXH
• UDI-Device Identifier: 00888912088541
• UDI-Public: (01)00888912088541
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2018

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: 803-00-015
• Device Lot Number: 184178L01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 10/25/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 425-01-007, LOT 057C1219
• Patient Age: 64 YR