MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. KNEE INSTRUMENT; SLAP HAMMER

Catalog Number	800-01-017
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the tip is broken; reported to have been left in the patient.
Additional Manufacturer Narrative
Date received by manufacturer: reported as 5/17/2016 on the initial mdr.Should be 6/20/2016.
Additional Manufacturer Narrative
The complaint form was unclear if a part of the broken extractor was left in the patient.It has been confirmed no part was left in the patient.Manufacturer narrative: the reason for this complaint was to report the tip of the slap hammer broke.This event occurred during inspection away from the patient.There was another suitable device available, the incident did not cause a delay in surgery, surgery was completed as intended and there was no risk to the patient noted.Examination of the returned slap hammer shows the extractor has broken off from the stop.The reported condition could possibly be a result of heavy use/misuse/wear and care must be taken to avoid compromising their performance.Refer to instrument instruction for use (ifu) 0400-0146 "recommendations for the care and handling for (b)(4) instruments.A review of the device history record (dhr) revealed the product was manufactured to revision level specifications.Based on the released date the instrument may have been in service for over 7 years.A review of the product complaint report history showed there have been (b)(4) prior complaints reported against this part: 15 broke/cracked/damaged, 1 siezed or galled, 11 blank.This is the first complaint against this lot number.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.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: KNEE INSTRUMENT
• Common Device Name: SLAP HAMMER
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 5740033
• Report Number: 1644408-2016-00461
• Device Sequence Number: 985
• Product Code: HWA
• UDI-Device Identifier: 00888912122139
• UDI-Public: (01)00888912122139
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2016

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
• Operator of Device: Health Professional
• Device Catalogue Number: 800-01-017
• Device Lot Number: 38268L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/21/2016
• Supplement Report FDA Received Date: 06/22/2016; 09/14/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1