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

Model Number	508-00-001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Primary surgery - while the surgeon was turning the screw, it over torqued and the head of the screw snapped off.The screw is not in the patient but the remaining shaft of the screw stayed in the baseplate/glenosphere.
Additional Manufacturer Narrative
The reason for this revision surgery was breakage of the baseplate capture screw during a primary surgery.The healthcare professional indicated there was a 5 minute delay in surgery and another suitable device was available for use.The primary surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was breakage of the baseplate capture screw during a primary surgery.To clarify the event a subsequent follow-up was initiated and it confirmed the baseplate is in the patient and the screw shaft is lodged in the baseplate.The head of the screw which broke off was removed and is not in the patient.Information provided stated the surgeon used a torque limiting driver during the surgery.No details were observed in the dhr that would indicate the screw would have been compromised or subject to breaking.None of the parts involved in this event have been returned for visual evaluation.No reports from the surgery of any concurrent events that may have contributed to this event.Cause of the actual break is not conclusive and undetermined.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.
Additional Manufacturer Narrative
Corrected data: manufacturer narrative: the reason for this revision surgery was breakage of the baseplate capture screw during a primary surgery.The in-vivo length is not a factor as this was the primary surgery.The healthcare professional indicated there was a 5 minute delay in surgery and another suitable device was available for use.The primary surgery was completed as intended.The device was disposed of at the hospital and not made available to djo surgical for examination.A review of the device history records (dhrs) revealed no discrepancies or issues with the manufacturing of this part.All critical dimensions, design criteria and specifications in effect at the time the part was manufactured were met.The aforementioned pertains to the screw and baseplate specifications.The product complaint report history was reviewed and no trends or on-going issues were deemed as present or in need of review.This event is deemed as non-product related.The root cause for this event was breakage of the baseplate capture screw during a primary surgery.To clarify the event a subsequent follow-up was initiated and it confirmed the baseplate is in the patient and the screw shaft is lodged in the baseplate.The head of the screw which broke off was removed and is not in the patient.Information provided stated the surgeon used a torque limiting driver during the surgery.No details were observed in the dhr that would indicate the screw would have been compromised or subject to breaking.Torque drivers from this agency were recently rotated for calibration.The torque values recorded for the returned drivers were within tolerance and did not contribute to this failure.None of the parts involved in this event have been returned for visual evaluation.No reports from the surgery of any concurrent events that may have contributed to this event.Cause of the actual break is not conclusive and undetermined.Inventory containment is not required since there are no indications of a product or process issue affecting implant safety or effectiveness.

• Brand Name: RSP SHOULDER
• Common Device Name: GLENOID, HEAD W/RETAINING SCREW, RSP, 32MM/NEUTRAL
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin TX 78758 5445
• MDR Report Key: 6569407
• Report Number: 1644408-2017-00356
• Device Sequence Number: 11035219
• Product Code: KWS
• UDI-Device Identifier: 00888912024617
• UDI-Public: (01)00888912024617
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2023
• Device Model Number: 508-00-001
• Device Catalogue Number: 508-32-101
• Device Lot Number: 862C2340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/17/2017
• Supplement Date Received by Manufacturer: 08/18/2017; 10/09/2017
• Initial Report FDA Received Date: 05/16/2017
• Supplement Report FDA Received Date: 09/14/2017; 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 508-32-101, LOT 862C2340; 508-32-104, LOT 866C2261
• Patient Age: 58 YR