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

Catalog Number	804-03-048
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported incident - while trying to engage the guide into the baseplate, the tip broke off inside the baseplate.The tip was left in the patient, part of item will be returned.
Additional Manufacturer Narrative
The instrument was returned on 11 feb 2019.When the reported event occurred the instrument may have been in service for 3.8 to 3.9 years.This event occurred during surgery away from the patient.There was not another suitable device available, however, the incident did not cause a delay in surgery, 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.A review of the device history record (dhr) revealed no discrepancies or issues with the manufacturing history of this part.Review of the complaint history indicates to date (b)(4)2019) 117 complaints have been reported against this part number.Th summary of complaints is as follows: 9- functional, 6- dull/worn, 1- fit, 1- locking mechanism damaged, 2- sized/galled, 12- threads damaged/galled, 3- missing feature, 1- missing component, 5- bent, 71- broke/cracked/damaged, 5- hardware missing/lost, 1- end of life.Of the 117 complaints, none are for this lot number.Examination of the returned drill guide shows the threaded tip of the thumb screw broken off (broken tip left in patient), confirming the complaint.This event is attributable to damage incurred from prolonged use and through misuse or rough handling which surgical instruments are subjected to.There are no indications that this instrument has a design or material deficiency therefore no containment of inventory is required.

• Brand Name: RSP SHOULDER 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: 8379875
• Report Number: 1644408-2019-00147
• Device Sequence Number: 16206444
• Product Code: FZX
• UDI-Device Identifier: 00888912148177
• UDI-Public: (01)00888912148177
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 804-03-048
• Device Lot Number: 167548L01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/28/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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: 62 YR