MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; GLENOID HEAD INSERTER/IMPACTOR

Catalog Number	804-03-051
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Instrument failure - the tip of the inserter broke off inside of the implant.The implant is still in the patient.Surgery was completed but not with the ideal out come with the broken piece left in patient.
Additional Manufacturer Narrative
The reason for this compliant was to report the tip of the insertor broke off inside of the implant.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, and there was no risk or adverse event reported.The device was not made available to djo surgical for examination.The reported condition could possibly be a result of heavy use or misuse and care must be taken to avoid compromising their performance.Refer to the instrument ifu.Complaint database review showed previous complaints but there were no indications that this instrument has a design or material deficiency.Summary of complaints: 1 functional, 2 dull/worn, 6 threads damaged/galled, 3 broke/cracked/damaged.The lot number was not reported; therefore, this instrument could not be linked to a specific device history record (dhr) and the actual date of manufacture cannot be determined with confidence.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 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: RSP
• Common Device Name: GLENOID HEAD INSERTER/IMPACTOR
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 9130288
• Report Number: 1644408-2019-00950
• Device Sequence Number: 2409601
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: (01)00888912148184
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: E241504
• 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): 11/18/2019

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: 804-03-051
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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: Required Intervention
• Patient Age: 66 YR