MAUDE Adverse Event Report: AESCULAP AG A-SPACE SIBD BONE SCREW 4.5X30MM; MPLANTS INTERBODY FUSION

Model Number SJ702T

Device Problem Device Issue (2379)

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

Event Date 05/02/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).The screwdriver rotated through, the screw blocked and could not be removed.

Manufacturer Narrative

Investigation: the screwdriver tip is made from 1.4543 and hardened.The screws are made from ti6al4v.Batch history review: the manufacturing documentation has been checked for all of the above listed lot numbers.There is no indication for a manufacturing error or material defect.Conclusion and root cause: the most likely root cause of the failure is user error.Rational: due to the fact that the tip of the screwdriver does not exhibit markings of being only half inserted into the screw head, and that the screw was almost fully inserted, it is assumed that the insertion torque required was simply too high for the screw head with a correctly inserted screwdriver.One likely cause for this is that the user did not pre-drill the holes.Another possible reason is patient related hard bone.The user manual recommends to drill a pilot hole prior to screw insertion.Corrective action: a capa is not necessary.

• Brand Name: A-SPACE SIBD BONE SCREW 4.5X30MM
• Type of Device: MPLANTS INTERBODY FUSION
• 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: 5692922
• MDR Text Key: 46365331
• Report Number: 3005673311-2016-00085
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SJ702T
• Device Catalogue Number: SJ702T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/20/2016
• Date Manufacturer Received: 05/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other