MAUDE Adverse Event Report: ENCORE MEDICAL L.P. RSP; 2.5MM RSP CENTRAL DRILL GUIDE

Model Number	804-03-036
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint - labeled as 15 degree, should be 10.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
The reason for this complaint was reported as mislabelling.The possible time in service for drill guide is 4 months from manufactured date.The healthcare professional indicated that this event occurred during inspection, away from the patient.There was no risk or adverse event reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The instruments were inspected prior to use and found to be unacceptable.The agent was present when this event occurred and was able to provide another suitable device.The device was returned to manufacturer and evaluated by registered medical assistant (rma) djo surgical.A review of the instrument's po receiver revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.However, on the receiver the item description states "drill guide, 2.5mm x 15dg angle".Complaint database review showed no previous complaints that allege this same issue.The root cause of this complaint is likely that within the system the drill guide was labeled as 15 degrees instead of 10, which led to the incorrect angle being printed on the label.The device was manufactured to the correct specifications and passes inspection, thus functionally acceptable.A review of inventory was completed and identified that all labels indicated 15 degrees instead of 10 degrees.The product was placed on mrb hold and will be reworked under ncmr(b)(4).The label has been updated under (b)(4), no additional containment is required.Product is conforming and can perform the required functions.Rma examination: the reported device was returned to djo surgical for evaluation.The label clearly indicates 15 degree angle instead of 10.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.
Additional Manufacturer Narrative
Corrected data: see h.10.Manufacturer narrative: the reason for this complaint was reported as mislabelling.The possible time in service for drill guide is 4 months from manufactured date.The healthcare professional indicated that this event occurred during inspection, away from the patient.There was no risk or adverse event reported by the surgeon.There was no delay in surgery and the surgery was completed as intended.The instruments were inspected prior to use and found to be unacceptable.The agent was present when this event occurred and was able to provide another suitable device.The device was returned to the manufacturer and made available at djo surgical for evaluation.A review of the instrument's po receiver revealed, when released for use, met design and manufacturing requirements.There were no ncmrs associated with the production of the instrument that is related to the reported issue.However, on the receiver the item description states "drill guide, 2.5mm x 15dg angle".Complaint database review showed no previous complaints that allege this same issue.The root cause of this complaint is likely that within the system the drill guide was labeled as 15 degrees instead of 10, which led to the incorrect angle being printed on the label.The device was manufactured to the correct specifications and passes inspection, thus functionally acceptable.A review of inventory was completed and identified that all labels indicated 15 degrees instead of 10 degrees.The product was placed on mrb hold and will be reworked under ncmr-65121.The label has been updated under dc-24074, no additional containment is required.Product is conforming and can perform the required functions.Rma examination: the reported device was returned to djo surgical for evaluation.The label clearly indicates 15 degree angle instead of 10.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

• Brand Name: RSP
• Common Device Name: 2.5MM RSP CENTRAL DRILL GUIDE
• Manufacturer (Section D): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer (Section G): ENCORE MEDICAL L.P.; 9800 metric blvd; austin, tx 78758-5445
• Manufacturer Contact: james mcmahon ; 9800 metric blvd; austin, tx 78758-5445
• MDR Report Key: 15365320
• Report Number: 1644408-2022-01119
• Device Sequence Number: 6485919
• Product Code: FZX
• UDI-Device Identifier: 00888912148061
• UDI-Public: (01)00888912148061
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 11/07/2022

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 Model Number: 804-03-036
• Device Catalogue Number: 804-03-036
• Device Lot Number: 363543L33
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 11/04/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/27/2022; 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown