MAUDE Adverse Event Report: SYNTHES GMBH CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	03.010.404
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
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.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.
Event or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the suprapatella nailing procedure was at the completion stage and the surgeon was about to put in an end cap but unable to remove the connecting screw.The surgeon than realized that the insertion handle had rotated during insertion which left it loose against the nail.This was also confirmed when we saw that one of the proximal screws had missed the nail even though it went through the aiming arm.He couldn¿t remove the connecting screw so, we removed the entire construct and were able to see that the nail had been damaged and managed to get the connecting screw to disengage.Later when proceeded to check the insertion handle and by only having one suprapatellar kit on the shelf, made the decision that although there was some minor marks on the insertion handle, when we assembled the nail and checked with the aiming arm, it seem secured.However, like the first time at the end, were about to remove the connecting screw to put the end cap in, it was not coming out and there was some movement again.Fortunately, after numerous tries, the surgeon was able to remove the connecting screw and used 8mm diameter nail.Procedure was completed successfully with ninety(90) minutes delay.This report is for one (1) cann connecting scr f/percutan instruments for nails-ex.This is report 2 of 6 for complaint (b)(4).

• Brand Name: CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12579250
• Report Number: 8030965-2021-08386
• Device Sequence Number: 1101183
• Product Code: FZX
• UDI-Device Identifier: 07611819501706
• UDI-Public: (01)07611819501706
• 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): 09/08/2021

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 Catalogue Number: 03.010.404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1