MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SURGICAL INSTRUMENT; DRILL GUIDE, TWO PIECE, RSP

Catalog Number	804-03-048
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the reverse shoulder prosthesis (rsp) glenoid drill guide broke off into the reverse shoulder prosthesis (rsp) glenoid baseplate.The threads sheared off into the component.Baseplate being returned under (b)(4).
Additional Manufacturer Narrative
The instrument was returned on 19 dec 2017.When the reported event occurred the instrument may have been in service for over 5.6 years.This event occurred during surgery near the patient.There was not another suitable device available, the incident did cause a 10 minute delay in surgery.A significant adverse event was reported; however, the surgery was completed as intended, and the instrument was inspected prior to surgery and was found to be acceptable.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of the instrument.The summary of complaints against the instrument is as follows: 7- functional, 6- dull/worn, 1- fit, 1- locking mechanism damaged, 2- seized/galled, 12- threads damaged/galled, 3- missing feature, 1- missing component, 5- bent, 67- broke/cracked/damaged, 5- hardware missing/lost, and 1- end of life.The summary of complaints against the instrument lot number is 10.Examination of the above returned items shows the threaded tip of the thumb screw broken off in the baseplate, confirming the complaint.The reported condition could possibly be a result of heavy use or misuse of the instrument and care must be taken to avoid compromising their performance.This event is due to the drill guide thumb screw threaded tip broke off in the baseplate.The damage is what surgical instruments are subjected to.This is not an event associated with a product failure, malfunction or issue.There are no indications that the instrument has a design or material deficiency therefore no containment of inventory is required.

• Brand Name: RSP SURGICAL INSTRUMENT
• Common Device Name: DRILL GUIDE, TWO PIECE, RSP
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 7131246
• Report Number: 1644408-2017-01180
• Device Sequence Number: 2145135
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 01/29/2018

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: 804-03-048
• Device Lot Number: 81902L02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 01/29/2018
• 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: 64 YR