MAUDE Adverse Event Report: SYNTHES GMBH UNK - END CAPS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unk - end caps/unknown lot.Part and lot numbers are unknown; udi number is unknown.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 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) unk - end caps.This is report 6 of 6 for complaint (b)(4).

• Brand Name: UNK - END CAPS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12579507
• MDR Text Key: 274831147
• Report Number: 8030965-2021-08389
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP; INSERT-HANDLE F/ETN F/SUPRAPATELLAR APPR; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAILS; UNK - SCREWS: TRAUMA