MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM INSTRUMENT; DIAMOND POINT AWL

Model Number	DPA1-000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.A review of the device history records (dhr) confirmed the device met all quality inspections and specifications prior to release.If any additional information is provided, a supplemental report will be submitted.
Event or Problem Description
Information was received that during the opening of the medullary canal without using force, the tool broke while rotating.As a result, the sharp part got stuck in the bone.
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned instrument was conducted.It was confirmed that the tool was broken at the top portion above the laser marking.Based on the information received and the type of breakage observed, it has been determined the reported breakage was likely caused by normal age, wear and tear.
Event or Problem Description
Additional information was received that the part that got stuck was able to be retrieved/taken out.

• Brand Name: PRECICE® INTRAMEDULLARY LIMB LENGTHENING SYSTEM INSTRUMENT
• Common Device Name: DIAMOND POINT AWL
• 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: 16771064
• Report Number: 3006179046-2023-00161
• Device Sequence Number: 16929009
• Product Code: HWJ
• UDI-Device Identifier: 00812258026578
• UDI-Public: 812258026578
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DPA1-000
• Device Lot Number: 150826-76
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2015
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 65 KG