MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; REAMER

Model Number	RMR1-070
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Despite attempts to obtain, no further event or product information has been provided and the device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
It was reported that during the procedure, the reamer cracked the bone.Despite attempts to obtain, no further event or product information has been provided.
Additional Manufacturer Narrative
Device evaluation: the precise flexible reamer was returned to nuvasive for investigation.A visual inspection confirmed that the tip of the reamer has been broken.The reported bone fracture was unable to be confirmed as no objective evidence was provided.Although the root cause is unable to be determined, it is likely that due to the age of the device the reamer experienced some wear and tear that contributed to the break.If the tip was worn due to age, it could have been inadequate for bone preparation, causing the surgeon to use off-axial forces during reaming that could have led to a break of both the instrument and the bone.Additionally, if the surgeon selected the incorrect reamer, it is likely that additional force may have been required to ream the bone and that could lead to a breakage of the instrument.
Event or Problem Description
No additional information has been provided at this time.
Event or Problem Description
It was additionally reported that during reaming the reamer stopped in the bone so the reamer was pulled out and the end stayed in the bone.
Additional Manufacturer Narrative
Device records review: a review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.

• Brand Name: PRECICE SYSTEM
• Common Device Name: REAMER
• Manufacturer (Section D): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer (Section G): NUVASIVE SPECIALIZED ORTHOPEDICS, INC.; 101 enterprise dr. ste 100; aliso viejo CA 92656
• Manufacturer Contact: geoff gannon ; 101 enterprise dr. ste 100; aliso viejo, CA 92656 ; 8583448112
• MDR Report Key: 16659357
• Report Number: 3006179046-2023-00158
• Device Sequence Number: 5973008
• Product Code: HTO
• UDI-Device Identifier: 00812258026622
• UDI-Public: 812258026622
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/20/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: RMR1-070
• Device Lot Number: A180110-86
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 04/14/2023; 09/12/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/19/2023; 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2018
• 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 Age: 17 YR
• Patient Sex: Female
• Patient Weight: 50 KG