MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD INTRODUCER; MISC ORTHO SURGICAL INSTR

Model Number	03.616.048
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 that the patient underwent for psf surgery using the matrix mis system.During the surgery, it was noticed that the mis rod holder was not holding the rod properly.The other matrix mis system was opened in order to remove the broken instruments.The surgery was completed and there were no consequences of the patient.This complaint involves 1 device.This report is for (1) rod introducer.This report is 1 of 1 for (b)(4).

• Brand Name: ROD INTRODUCER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11120270
• Report Number: 2939274-2021-00029
• Device Sequence Number: 3698280
• Product Code: LXH
• UDI-Device Identifier: 10705034716381
• UDI-Public: (01)10705034716381
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 03.616.048
• Device Catalogue Number: 03.616.048
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 01/05/2021
• Patient Sequence Number: 1