MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXP TI UNI SCREW 6MM X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number	179788645
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On (b)(6) 2017, surgery for idiopathic scoliosis was performed using the expedium system.The parts to fix were t8 -l3.During the surgery, the following issues were confirmed.The surgeon completed the correction of scoliosis and vertebral rotation using the screw (part#: 179788645, lot#: tblfr).At the time of final tightening, he could not insert a counter (par# & lot#: unk) to this screw because the screw did not accept the counter.He successfully removed the screw in question and then inserted a new screw to the location where the screw in question had been inserted.The surgery was completed with a 10-minute delay, and there was no adverse consequence to the patient.This event was postoperatively reported to our sales person and the reported product was already collected.No further information has been provided from the hospital.
Additional Manufacturer Narrative
Udi: (b)(4).One (1) exp ti uni scw 6mm x 45mm was returned for evaluation.Visual examination of the screw revealed that the inner cap (saddle) is dislodged to a certain degree from its intended location.The edges of the saddle are bent, consistent with a rod being forced in to the tulip head with dislodged saddle.It was also noted that the threads inside the tulip head were slightly worn with minor damage to the drive feature.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 screw falling apart cannot be determined from the sample and the information provided.A potential root cause may be excessive force inadvertently placed on the drive feature of the screw during tightening, potentially at a significant angle, resulting in the screw disassembling during use.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.

• Brand Name: EXP TI UNI SCREW 6MM X 45MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6905506
• Report Number: 1526439-2017-10778
• Device Sequence Number: 19055075
• Product Code: NKB
• UDI-Device Identifier: 10705034081403
• UDI-Public: 10705034081403
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2017

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
• Operator of Device: Physician
• Device Catalogue Number: 179788645
• Device Lot Number: TBLFR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Initial Date Received by Manufacturer: 09/06/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 10/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1