MAUDE Adverse Event Report: SYNTHES USA; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Device Problem Difficult to Remove (1528)

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

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

Patient initials: (b)(6).This report is for an unknown uss screw/unknown lots at unknown level.Part and lot numbers are unknown; udi number is unknown.Partial part number 498.Xxx provided.Additional product codes: mnh, mni.Device reportedly was not able to be explanted.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It is reported during the revision of a posterior spine fusion from t11 to ilium using the universal spine system variable axis screws (uss vas iii) system, two (2) screwdriver tips were broken and one (1) screwdriver tip was bent.While replacing the uss vas iii screws at l2 and l4, a large amount of torque was required.At an unknown level, the tip from one of the 3.0mm hexagonal screwdriver with t-handle, as well as the tip from the 3.0mm hexagonal screwdriver shaft 230mm hxc broke off in the screw head of the uss vas iii screws.The fragments could not be retrieved and the screws could not be removed.Surgeon opted to leave the screws in the patient.Fragments also remain implanted in the patient.The tip of another 3.0mm hexagonal screwdriver with t-handle became extremely deformed during this procedure.Procedure was completed successfully with no delay and no harm to patient.The revision procedure is addressed on linked complaint (b)(4).This report is for an unknown uss screw.This is report 5 of 5 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.This determination is for an unknown screw at an unknown level that interacted with a screwdriver tip that became bent.There is no information to suggest that this screw was retained by the patient unintentionally.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

The initial complaint was reviewed and found not reportable.The information in this complaint record reasonably suggests that a device malfunction has occurred, and the device malfunction has not caused or contributed to a death or serious injury, nor has the device malfunction caused a permanent impairment to a body structure, or required medical or surgical intervention to preclude permanent impairment of a body function, or permanent damage to a body structure, and the recurrence of this malfunction is not likely to cause or contribute to a death or serious injury if it were to recur.This determination is for an unknown screw at an unknown level that interacted with a screwdriver tip that became bent.There is no information to suggest that this screw was retained by the patient unintentionally.

• Type of Device: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5605792
• MDR Text Key: 43585681
• Report Number: 2520274-2016-12267
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 151