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

Catalog Number	804-03-008
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2020-00072; 804-03-008, s303-broke/cracked/damaged, instrument failure.If additional information regarding the reported event is submitted at a future date, this investigation will be re-evaluated.Rma examination: the instrument was not returned to djo for further examination, per product feedback form, the instrument has been discarded.No further evaluation can be made for this event.This customer complaint will be closed.
Event or Problem Description
It was reported there was a 30 minute delay in surgery.

• Brand Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer (Section G): ENCORE MEDICAL L.P; 9800 metric blvd; austin TX 78758
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, TX 78758
• MDR Report Key: 19056507
• Report Number: 1644408-2024-00413
• Device Sequence Number: 7069131
• Product Code: FZX
• UDI-Device Identifier: 00888912147842
• UDI-Public: 00888912147842
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: E529269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 804-03-008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 04/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown