MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 ADJUSTABLE CROSS CONNECTOR 60-77MM; S4 IMPLANTS

Model Number SW497T

Device Problem Structural Problem (2506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The first connector : the surgeon tightened three hexagon screws of the connector, using a torque wrench((b)(4)), starting from both sides, then the middle one.However, when attempting to tighten the middle screw, it continues to rotate idly and would not complete tightening under 4n/m.The first connector was replaced.But the same event occurred to the second connector as well.The surgeon attempted to loosen the screws , but one of the two screws exhibited deformed hexagon and the screw would not loosen any further.Therefore, unable to remove the connector from the rod.The surgeon replaced the rod and the connector at the same time to replace the second connector.The surgical procedure was extend for about 15 minutes.The procedure was completed without cross connector in the end.The surgeon pointed; the strength/durability of the screw.Wear/damages of the wrench.All med watch submissions related to this report are: 9610612-2018-00315, 9610612-2018-00316, 9610612-2018-00317, 9610612-2018-00318.

Manufacturer Narrative

Investigation: used test and analysis equipment: keyence vhx 5000 digital microscope.Panasonic dmc tz8 digital camera.Fw207r torque screwdriver.We made a visual inspection of both connectors.At connector "a" we noticed a clamped third party rod.The hexagon of the clamping screw of this segment is completely damaged.In the next step we investigated the center screw.Here we found that the screw was in a skewed position.At last we tried to fix the center screw with a 4nm screwdriver.The screw slips without any noticable force.In the next step we investigated connector "b".Here we found no outward abnormalities.The center screw was in the correct position.Also her we tried to fex the center screw with a 4nm screwdriver.The screw slips without any noticeable force too.Batch history review: the manufacturing documents of both lots have been checked and found to be according to specificaiton valid during the time of production.There are no further complaints with those lots at hand the last three years.Conclusion and root cause: the root cause of the problem is most probably usage related.Rational: the thread of the center screw of both connectors is definitely overtorqued.Both connectors are out of completely different production lots, so a manufacturing problem or a material defect can be excluded.The ifu points out the need of the correct torque during tightening the connector screw.No capa is necessary.

• Brand Name: S4 ADJUSTABLE CROSS CONNECTOR 60-77MM
• Type of Device: S4 IMPLANTS
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 7728517
• MDR Text Key: 115540939
• Report Number: 9610612-2018-00315
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K060285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW497T
• Device Catalogue Number: SW497T
• Device Lot Number: 51493496
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Distributor Facility Aware Date: 07/03/2018
• Device Age: 10 YR
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other