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

Catalog Number	804-03-051
Medical Device Problem Codes	Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that piece left in patient.
Additional Manufacturer Narrative
Complaint has been evaluated and is similar to previous report number 1644408-2022-00617; 804-03-051, 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.

• Brand Name: GLENOID HEAD INSERTER/IMPACTOR
• Common Device Name: IMPACTOR
• 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: 18323651
• Report Number: 1644408-2023-01748
• Device Sequence Number: 7358747
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: 00888912148184
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: E241504
• 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): 12/13/2023

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: 804-03-051
• Device Lot Number: 274186L02
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 803-05-163 LOT: 304762L01.; 803-05-167 LOT: 381859L02.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female