MAUDE Adverse Event Report: SYNTHES GMBH DISTAL FEMUR LISS INSERTION GUIDE-LEFT; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	324.011
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
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.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a procedure on an unknown date there was a wear and tear of fixation bolt for less invasive stabilization system (liss) insertion guide and the liss insertion guide was also unable to be fully secured due to inability to tighten successfully due to stripping during tightening.There was a twenty (20) minutes of surgical delay as surgeon had to do a longer incision for a very long plate instead of using a minimal invasive jig.Patient outcome is reported as longer incision to recover from.No further information provided.This report is for one (1) distal femur liss insertion guide-left this is report 2 of 2 for complaint (b)(4).

• Brand Name: DISTAL FEMUR LISS INSERTION GUIDE-LEFT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11674787
• Report Number: 8030965-2021-02964
• Device Sequence Number: 3156722
• Product Code: FZX
• UDI-Device Identifier: 07611819225640
• UDI-Public: (01)07611819225640
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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 Catalogue Number: 324.011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention