MAUDE Adverse Event Report: PRECISION SPINE, INC LONG K-WIRE- NITINOL; PASSER, WIRE

Catalog Number 48-9016

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

Tip of nitinol guidewire remains in patient's bone (retained foreign object).Evaluation in process but not yet complete.Upon completion of evaluation, a follow up report will be submitted.Evaluation in process, not yet complete.

Event Description

It was reported that a 2 level plif l4-s1 fixation was performed in (b)(6) on (b)(6) 2016, to address lumbar spinal stenosis.Pss screws were used for an open case.Guidewires were used for inserting the screws due to the long screwdriver obstructing the view.Six guidewires were placed and the position was confirmed, then the screws were inserted.When the 5th screw (l5 left) was being inserted, a cracking sound was heard and it was confirmed that the guidewire (long k-wire- nitinol p/n 48-9016) had broken about 10mm from the tip.A tap was used to insert the screw and all other screws were inserted successfully without issue.The broken tip of the k-wire was unable to be removed and remains in the patient's bone.

Manufacturer Narrative

Dimensional evaluation performed by quality found the returned product conforms to design specifications for the portion of the device remaining.Engineering evaluation of the returned guidewire and manufacturing history inspection sheets did not find any deviations or anomalies.The fracture occurred at the root of the thread and appears to be a shear fracture.Details provided regarding the incident were not enough to make any conclusions as to the cause of the fracture.The breakage may have been attributed to off axis loading while inserting the screw, as the incident notes indicated that the screw driver was obstructing the view of the surgeon for being too long.The surgical technique (lbl-stg-022) surelok slc extended tab pedicle screw system, indicates that k-wires should not be reused if deformed, in order to prevent the k-wire from becoming obstructions in a mating cannulated instruments.Although the exact cause of the fracture could not be confirmed, there was no evidence found that would suggest product error was a contributing factor.Review of manufacturing history records found a total of (b)(4) pieces of this lot were released for distribution on 7/10/2014 with no deviation or anomalies.A two-year complaint history review did not reveal any previous reports of this nature for the reported lot / design revision.As the root cause is likely attributed to off axis loading and no product non-conformance was identified, the need for corrective action was not indicated.

• Brand Name: LONG K-WIRE- NITINOL
• Type of Device: PASSER, WIRE
• Manufacturer (Section D): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer (Section G): PRECISION SPINE, INC; 2050 executive drive; pearl MS 39208
• Manufacturer Contact: beth albert ; 2050 executive drive; pearl, MS 39208 ; 6014204244
• MDR Report Key: 5625639
• MDR Text Key: 44333579
• Report Number: 3005739886-2016-00021
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 48-9016
• Device Lot Number: 0701141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/05/2016
• Initial Date FDA Received: 05/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR