MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MULTIAX.CROSS CONN.45-58MM STER; SPINE SURGERY

Model Number SX937TS

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with product ennovate multiax.Cross connector.Following information was reported: "after measuring, the cross connector of 48mm was selected by the surgeon.He first loosened all the three screws in the connector.Then he mounted the cross conector on the rods and tentatively tightened the screws.Then he final-tightened all the screws using the designated instrument, however the screw in the middle kept on spinning and would note be fixed.He attempted the tightening procedure several times with no success.He stopped using the cross connector and picked up another cross connector, but this one did not fit the distance between the rods physically.In the end, the surgeon finished the surgical procedure without the cross connector.Aftere several attempts to tighten the cross connector, there was surgical delay, but not exactly known if it exceeded 15 minutes or not." the malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

General information: intra operative incident.According to the available information, there were no negative consequences for the patient.Investigation: in the first step, we tried to fix the center screw.This was not possible, it kept on spinning as described in the complaint.In the next step we investigated the root cause for this behavior.For this we made a visual inspection of the center screw.Here we noticed a sheared off thread.Batch history review: the manufacturing documents have been checked and found to be according to specification valid during the time of production.There are no further complaints with this lot at hand.Conclusion and root cause: the root cause for the problem is most probably usage related.Rationale: without further knowledge about the circumstances we assume, that the screw was tightened with too high torque.A material failure or a manufacturing error can be excluded.Corrective action: according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: ENNOVATE MULTIAX.CROSS CONN.45-58MM STER
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9633222
• MDR Text Key: 179493038
• Report Number: 9610612-2019-00920
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• PMA/PMN Number: K180433
• 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: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SX937TS
• Device Catalogue Number: SX937TS
• Device Lot Number: 52503217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3 SCREWS.; RODS.