MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP SHOULDER; GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM

Model Number 508-32-103

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  Injury  

Event Description

Complaint - a hair was found in the sterile packaging, second to last sterile pack.Part was still used in case.

Manufacturer Narrative

The reason for this complaint was a hair was found in the sterile packaging, second to last sterile pack.Part was still used in the case, primary surgery.The healthcare professional indicated there was no delay in surgery and another suitable device was available for use.The surgery was completed as intended.The item was not made available to djo surgical for examination.A review of the implant device history records (dhr), shows that the reported component used in the surgery, when released for use, met design and manufacturing requirements.There were no non-conforming material reports associated with the product that may have contributed to the reported event.The device was verified to have gone through an acceptable sterilization process and was within its expiration date at the time of the previous surgery.Customer complaint history of the reported device showed no present trends or on-going issues that are in need of review.The root cause of this complaint was a hair was found in the sterile packaging.There were no findings during this investigation that indicate that the reported device was defective.There are multiple factors that may contribute to an event that are outside of the control of djo surgical.

• Brand Name: RSP SHOULDER
• Type of Device: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/-4MM
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 8488148
• MDR Text Key: 141080855
• Report Number: 1644408-2019-00288
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 00888912024747
• UDI-Public: (01)00888912024747
• Combination Product (y/n): N
• PMA/PMN Number: K051075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 508-32-103
• Device Catalogue Number: 508-32-103
• Device Lot Number: 864C3366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR