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

Model Number SY635TS

Device Problem Dull, Blunt (2407)

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

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the implant arrived in a contaminated condition.At first sight the implant exhibits no damage or defects.Investigation - we made a visual inspection of the screw, especially the tip and compared it with the construction/drawing.Here we found no deviations or other possible root causes for the described problem.Batch history review - the manufacturing documents have been checked and found to be according to specifications 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 hole was not properly prepared.The tip/shape of the screw is according to the specification.

Event Description

It was reported that there was an intraoperative issue with ennovate screw placement.The surgeon had difficulty with insertion of the first screw in lwk3 because it was felt that the tip was too blunt.A tap had been used and a k-wire; the tap had not grasped despite preparation with an awl and high-speed drill.Two unsuccessful attempts were made to place the screw.Ultimately, a different screw was inserted from another manufacturer which was noted as having direct "grip".Details about the surgical outcome and patient data were not provided.Additional information has been requested.

• 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 8336912
• MDR Text Key: 137707935
• Report Number: 9610612-2019-00054
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180433
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SY635TS
• Device Catalogue Number: SY635TS
• Device Lot Number: 52482495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/29/2019
• Device Age: 1 MO
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1