MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER

Catalog Number	804-03-008
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reason for this complaint was to report that the tap snapped, while surgeon reaming.Bone tap's possible time in service is 4.3 years.This event occurred during surgery near the patient.There was another suitable device available, the incident did cause a 15 min.Delay in surgery, however 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.Part of the device was returned to djo surgical on 30 jan 2020.Examination confirmed the complaint, the returned bone tap is broken at the cutting flutes.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 the ifu.A review of the device history record (dhr) revealed, when released for use, met design and manufacturing requirements.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.There had been one previous complaint against the reported lot number.Summary of complaints: 5 functional, 16 dull/worn, 1 locking mechanism damaged, 6 seized/galled, 4 threads damaged/galled, 25 bent, 40 broke/cracked/damaged, 1 device cracked/broke, 5 end of life, 19 blank.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.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.
Event or Problem Description
Instrument failure - the surgeon was reaming and the tap snapped where the threads begin.No piece was left in the patient.

• Brand Name: RSP
• Common Device Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445,
• MDR Report Key: 9729343
• Report Number: 1644408-2020-00072
• Device Sequence Number: 3086724
• Product Code: HTO
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 804-03-008
• Device Lot Number: 181044L01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1