MAUDE Adverse Event Report: ENCORE MEDICAL L.P. SHOULDER INSTRUMENT; DRILL BIT, 1/8"

Catalog Number	801-01-020
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the surgeon was drilling at an incorrect angle and the drill bit snapped.When trying to retrieve it the surgeon just managed to push it in farther.Left in patient.
Additional Manufacturer Narrative
The reason for this complaint was to report , " the surgeon was drilling at an incorrect angle and the drill bit snapped.When trying to retrieve it the surgeon just managed to push it in farther.Left in patient." the incident did cause a 30 mininut delay in surgery and a significant adverse event was noted, however, there was another suitable device available, the surgery was completed as intended and the instrument was inspected prior to surgery and was found to be acceptable.The instrument revision level or lot number was not reported therefore a review of the device history record (dhr) was not performed or the time in service could not be determined with confidence.A complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 12 dull/worn, 25 mixed product/label, 1 bent, 21 broke/cracked/damaged, 1 device cracked/broke, 10 end of life, 11 blank.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.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.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: SHOULDER INSTRUMENT
• Common Device Name: DRILL BIT, 1/8"
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd.; austin TX 78758 5445
• MDR Report Key: 6682063
• Report Number: 1644408-2017-00625
• Device Sequence Number: 18869528
• Product Code: HTW
• UDI-Device Identifier: 00888912042710
• UDI-Public: (01)00888912042710
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

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: 801-01-020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 06/30/2017
• Supplement Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 78 YR