MAUDE Adverse Event Report: AESCULAP AG ENNOVATE POLYAX.SCREW 6.5X50MM CANULATED; IMPLANTS POSTERIOR STABILISATION

Model Number SY635TS

Device Problem Accessory Incompatible (1004)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/26/2020

Event Type  Injury  

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 polyax.Screw.Following information was reported: the screw could not be implanted.The incident occurred during spine surgery l5,s1.After rod insertion the caudal screws were blocked and fixed with setscrew.It was not possible to tighten the set screw on the left side with a torque wrench.Decision was made to place a new screw with the diameter 7.5mm instead of 6.5mm; but it was also not possible.Changed to t-handle and the set screw could be tightened.Surgery extension time was about 25 minutes.An additional medical intervention was necessary.The surgeon needed to use a larger screw.Additional information was not provided nor available the adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00078 ((b)(4) + sz228r).

Manufacturer Narrative

Associated medwatch report: 9610612-2020-00078 (400466454 sz228r).General information the implant (screw) and the torque wrench arrived in decontaminated condition.Consequences for the patient intra- operative medical intervention was necessary.Investigation in the first step we made a visual investigation of the pedicle screw.Here we found the thread in the body partially damaged at both sides.In the next step we measured the trigger- torque of the enclosed torque wrench.The trigger value was exact 10 nm and therefore within its specification.The service time is exceeded.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.5.Rationale without further knowledge about the circumstances we assume, that the damage of the thread in the body was caused by a tilted applied set screw (not enclosed).A proper tightening of the rod with such a pre- damaged screw is not possible.A material defect 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 POLYAX.SCREW 6.5X50MM CANULATED
• Type of Device: IMPLANTS POSTERIOR STABILISATION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9841873
• MDR Text Key: 183942428
• Report Number: 9610612-2020-00077
• 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
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY635TS
• Device Catalogue Number: SY635TS
• Device Lot Number: 52401555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention