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

Catalog Number 804-03-051

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/15/2023

Event Type  Injury  

Event Description

It was reported that piece left in patient.

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
• Type of Device: 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
• MDR Text Key: 330427965
• Report Number: 1644408-2023-01748
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 00888912148184
• UDI-Public: 00888912148184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E241504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 804-03-051
• Device Lot Number: 274186L02
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 803-05-163 LOT: 304762L01.; 803-05-167 LOT: 381859L02.
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Female