MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWDRIVERS

Device Problems Mechanical Problem (1384); Compatibility Problem (2960)

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

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown screwdriver/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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) 2020, during an unknown procedure, upon insertion of the screw into the patients vertebral body the synapse screwdriver/ screw became very difficult to drive forward and began to make a grinding/ creaking noise.At this point the screw was around 80% inserted and the surgeon felt that by attempting to drive the screw in any further would result in either the screw or the driver breaking in situ.It also behaved in the same way while the surgeon attempted to back the screw out by turning the driver anti-clockwise.It appeared as if the poly head of the screw was rotating around the shank of the screw without driving the screw itself forwards or backwards.As a result the driver would neither drive forward or back out the screw so surgeon had to detach the driver from the screw, insert a short rod and set screw and then helicopter the screw out by hand.The screw came out fully intact, a new screw was selected which went in without any problems and the surgery continued as planned.There was a surgical delay of thirty (30) minutes.The surgery was completed successfully with no further complications.Concomitant device reported: 4.5mm ti cancellous polyaxial screw 30mm for 4.0mm rods (part # 04.615.230s, lot # 3l40061, quantity 1).This report is for one (1) unknown screwdriver.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - SCREWDRIVERS
• Type of Device: SCREWDRIVERS
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11096706
• MDR Text Key: 247976327
• Report Number: 8030965-2020-10047
• Device Sequence Number: 1
• Product Code: HXX
• 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: 12/02/2020

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1