MAUDE Adverse Event Report: ENCORE MEDICAL, L.P. RSP SHOULDER INSTRUMENT; GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER

Catalog Number	804-03-008
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Instrument failure - tap broke during the case in the glenoid.
Additional Manufacturer Narrative
Manufacturer narrative: the reason for this complaint was a primary surgery reported as broken tap in the glenoid.The possible time in service for baseplate is 3 years and 11 months from manufactured date.The healthcare professional indicated that this event occurred during surgery, near the patient.No risk or adverse event was reported by the surgeon.The surgery was completed as intended, with a ten-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 device was returned to manufacturer and made available at djo surgical for examination.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 non-conformance material report (ncmr) associated with the production of the instruments that are related to the reported issue.Complaint database review shows twenty-three prior complaints filed against the instruments' item number.Complaint database review shows no prior complaints filed against the instruments lot number that reports a similar failure.No prior complaints report past instances of these instruments being affected by this failure.The root cause for this complaint is likely due to bending and/or torsional loads in excess of material capabilities.The location of the failure at the depth marking groove is the most likely location for failure to occur, since it is the location of smallest shaft cross-section.It is possible fatigue was a factor, and that the initiating overload event occurred during a previous surgery.Other factors such as hard bone may also have played a role.There are no indications that this instrument has a systemic design or material deficiency.Therefore, no containment of inventory is required.Event is associated with instrument usage, not a design or manufacturing issue.Rma examination: the instrument was returned to djo, and examination shows the guide, reamer, bone tap, 6.5mm, rsp, shoulder snapped in half at the depth line, confirming the complaint.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP SHOULDER INSTRUMENT
• Common Device Name: GUIDE, REAMER, BONE TAP, 6.5MM, RSP, SHOULDER
• Manufacturer (Section D): ENCORE MEDICAL, L.P.; 9800 metric blvd.; austin TX 78758 6313
• MDR Report Key: 12410945
• Report Number: 1644408-2021-00924
• Device Sequence Number: 19814569
• Product Code: HTO
• UDI-Device Identifier: 00888912147842
• UDI-Public: (01)00888912147842
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Catalogue Number: 804-03-008
• Device Lot Number: 247328L01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/01/2021
• Supplement Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR