MAUDE Adverse Event Report: RTI SURGICAL 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER; MISC ORTHO SURGICAL INSTR

Model Number	03.221.017
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the surgeon experienced a problem when attempting to lock the 1.7mm cable lock for pistol grip cable tensioner.There was no patient consequence.There was a surgical delay of one minute.The procedure was successfully completed.This report is for one (1) ø1.7mm cable lock for pistol grip cable tensioner.This is report 1 of 1 for (b)(4).

• Brand Name: 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): RTI SURGICAL; 375 river park circle; marquette MI 49855
• MDR Report Key: 11329856
• Report Number: 1833824-2021-00020
• Device Sequence Number: 16789562
• Product Code: LXH
• UDI-Device Identifier: 10886982076779
• UDI-Public: 10886982076779
• 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): 01/27/2021

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 Model Number: 03.221.017
• Device Catalogue Number: 03.221.017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1