MAUDE Adverse Event Report: ENCORE MEDICAL L.P RETRACTOR, DELTOID

Catalog Number	804-00-098
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Muscle/Tendon Damage (4532)
Date of Event	03/04/2024
Type of Reportable Event	Serious Injury
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
It was reported that despite appropriate interoperative use of the deltoid retractor, the anterior part of the deltoid muscle was severed by the edges of the retractor.
Additional Manufacturer Narrative
The agent reported that (despite appropriate interoperative use of the deltoid retractor, the anterior part of the deltoid muscle was severed by the edges of the retractor) this event occurred during surgery, near the patient.Significant adverse event was reported by the surgeon.The surgery was completed as intended, with a thirty-minute delay.The instrument was inspected prior to use and was deemed acceptable for use based on its appearance.The agent was present during surgery and was able to source a suitable replacement device.The instrument was not returned to djo surgical for further examination, two follow ups have been issued for the return of the instrument.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.A review of the instrument's device history record (dhr) revealed the instrument, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of this instrument.Complaint database review showed no previous complaints and there were no indications that this instrument has a design or material deficiency.The root cause of this complaint is due to surgical technique that led to a mishap, cutting into the muscle of the patient.This is not an event associated with a product failure, malfunction, or issue.

• Brand Name: RETRACTOR, DELTOID
• Common Device Name: RETRACTOR
• 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: 19029784
• Report Number: 1644408-2024-00374
• Device Sequence Number: 7020378
• Product Code: GAD
• UDI-Device Identifier: 00888912146203
• UDI-Public: 00888912146203
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: D468185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2024

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: 804-00-098
• Device Lot Number: 401334L01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: 05/10/2024
• Initial Report FDA Received Date: 04/02/2024
• Supplement Report FDA Received Date: 05/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2023
• 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; Disability; Hospitalization
• Patient Sex: Unknown