MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER INSTRUMENT; GUIDE, DRILL 3.2MM BASEPLATE RSP SHOULDER

Catalog Number	804-03-009
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure/primary surgery: due to the set screw breaking while trying to use the guide on the patient.
Additional Manufacturer Narrative
The reason for this complaint was to report the breakage of the set screw while the surgeon was trying to use the guide on a patient.When the reported event occurred the instrument may have been in service for over 3.1 years.The healthcare professional indicated there was a 30 minute delay in surgery and another suitable device was available for use.The surgery was completed as intended.The device was returned to djo surgical for examination.Examination of the returned guide confirmed the thumb screw threaded tip has broken off (broken threaded piece not returned).The reported condition can be indicative of excessive torque applied via the hex driver and possibly be a result of heavy use/misuse/wear and care must be taken to avoid compromising their performance.Refer to instrument instructions for use (ifu) 0400-0146 "recommendations for the care and handling for djo surgical instruments.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.A review of the product complaint report history showed there have been 103 prior complaints reported against this part number; summary of investigations: 7 functional, 6 dull/worn, 1 fit, 1 locking mechanism damaged, 2 seized/galled, 11 threads damaged galled, 3 missing feature, 5 bent, 61 broke/cracked/damaged, 5 hardware missing/lost, 1 end of life.This is the fifth complaint against this lot number.A review of the device history record (dhr) revealed the product was manufactured to revision level specifications.This root cause of 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.There are no indications of a product or process issue therefore no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.

• Brand Name: RSP SHOULDER INSTRUMENT
• Common Device Name: GUIDE, DRILL 3.2MM BASEPLATE RSP SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758
• MDR Report Key: 6102790
• Report Number: 1644408-2016-00857
• Device Sequence Number: 19045674
• Product Code: FZX
• UDI-Device Identifier: 00888912147859
• UDI-Public: (01)00888912147859
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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
• Report Date (Section B): 02/01/2017

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: 804-03-009
• Device Lot Number: 115666L03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/17/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 02/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR