MAUDE Adverse Event Report: RTI SURGICAL 1.0MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER; MISC ORTHO SURGICAL INSTR

Model Number	03.221.016
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional 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.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) 2020, when the surgeon was tightening 1.7 mm cables, using the pistol grip gun, the cable lock on the back end of the gun would not stay in the locked position.There was a five (5) minute surgical delay.No fragments were generated.The procedure was completed successfully.Patient outcome was unknown.Concomitant device reported: cable (part number unknown, lot unknown, quantity unknown), cable tensioner (part number unknown, lot unknown, quantity 1).This report involves one (1) 1.0mm cable lock for pistol grip cable tensioner.This is report 2 of 2 for (b)(4).

• Brand Name: 1.0MM 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: 10122769
• Report Number: 1833824-2020-00049
• Device Sequence Number: 19564233
• Product Code: LXH
• UDI-Device Identifier: 10886982076762
• UDI-Public: (01)10886982076762
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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: 03.221.016
• Device Catalogue Number: 03.221.016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - CABLE/WIRE; UNK - TENSIONING INSTRUMENTS
• Patient Age: 89 YR