MAUDE Adverse Event Report: DEPUY SYNTHES SPINE POLYAXIAL SCREW, TI, 5.5MM X 9.0MM X 100MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179712999

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 broke during manipulation.During surgery dr (b)(6) was manipulating the pelvic screw and the tulip head of the screw broke off.

Manufacturer Narrative

(b)(4).The expedium ti 9x100mm polyaxial screw head [product code: 1797-12-999, lot number: rl198796] was returned for evaluation.The screw shaft was not returned.There was little observable damage to the tulip head.The saddle is in place, the threads are intact, and there is no damage to the exterior of the tulip head.Dhr review identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.A review of the complaint trend analysis was performed and no emerging trends were identified as a result of the analysis.A root cause cannot be determined from the sample and the information provided.A potential root cause may be an unexpectedly high amount of force was placed on the screw head during the insertion and tightening of the polyaxial screw.No issues were identified during the manufacturing and release of this device that could have contributed to the problem reported by the customer.No systemic trends were observed.Therefore this complaint file will be closed with no further action required.

• Brand Name: POLYAXIAL SCREW, TI, 5.5MM X 9.0MM X 100MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5108546
• MDR Text Key: 26941027
• Report Number: 1526439-2015-10824
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK101993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 179712999
• Device Lot Number: RL198796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2014
• 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: 61 YR