MAUDE Adverse Event Report: DEPUY SYNTHES SPINE LONG SHANK MINIPOLY SCREW, 3.5 X 3.5 X 36MM(SUMT); ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 188320336

Device Problem Torn Material (3024)

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

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The mountaineer 3.5x36mm long shank screw (product code: 1883-20-336, lot number: 6431w) was returned to the complaints handling unit (chu).The tulip head of the screw did not immediately appear to have been splayed.In order to ensure that this observation was correct, the outer diameter of the tulip head was measured in the middle as well as at its top rim.The outer diameter at the middle was found to be 8.754mm while the outer diameter at the top rim was found to be 8.752mm.Both outer diameter measurements were well within the tolerance range of 8.75mm ± 0.05mm.Further examination of the tulip head found that the threads on one side of the tulip head were torn off.It may have given the impression that the head had splayed, as the inner set screw could not be properly tightened and spun inside the tulip head.This may have happened if the inner set screw was cross threaded upon insertion.Tightening the set screw in this configuration would place a great deal of force upon the threads inside the tulip head, resulting in them being torn off.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.No emerging trends were found requiring further actions.The root cause of the threads inside the tulip head tearing cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading the set screw during insertion, leading to the threads tearing during an attempt to tighten the set screw.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends requiring immediate action have been observed, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Screw head splayed during provisional tightening during compression maneuver.

• Brand Name: LONG SHANK MINIPOLY SCREW, 3.5 X 3.5 X 36MM(SUMT)
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5536616
• MDR Text Key: 41546291
• Report Number: 1526439-2016-10247
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK151885
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 188320336
• Device Lot Number: 6431W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2005
• 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
• Patient Age: 40 YR