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

Catalog Number	804-03-008
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Instrument failure - due to during the tapping process, the tap snapped off inside the glenoid.Dr.Redirected the drill and placed the baseplate inferior of the broken tap.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for the instrument failure was the tap snapped off inside the glenoid.This event occurred during surgery, near the patient.No risk, adverse event, or negative outcome were reported by the surgeon.The surgery was completed as intended, without delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery but was not able to source a suitable replacement device when the incident tap broke.This investigation is limited in scope as only partial information was provided to djo surgical for review.The revised items were not returned for examination and the lot numbers were not provided.To adequately investigate this event, the lot numbers are necessary.Given the limited information, a search of djo and available zimmer biomet records for the previous surgery produced no results, therefore; the items could not be verified.If this information is submitted at a future date, this investigation will be re-evaluated.Without a lot number reported, no further evaluation can be made for this event.This customer complaint will be closed.If the device is returned later, the complaint will be updated.Customer complaint history of the reported items showed no present trends or on-going issues that are needing a review.There was no information submitted with this complaint about any patient activities, accidents, or medical contraindications that may have contributed to the reported event.The surgeon performed this revision to remedy the patient's condition.This complaint will be closed pending receipt of additional information.No further action is deemed necessary at this time.Rma examination: the reported instrument was not returned to djo for examination.The complaint form indicates it was discarded.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: REVERSE SHOULDER PROSTHESIS INSTRUMENT
• 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: 11638426
• Report Number: 1644408-2021-00308
• Device Sequence Number: 17074252
• Product Code: HTO
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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 Expiration Date: 02/22/2021
• Device Catalogue Number: 804-03-008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/22/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 04/08/2021
• Supplement Report FDA Received Date: 10/12/2021
• 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: 73 YR