MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179704890
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation will be conducted.A follow up will be filed with the results.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 vertebral osteomyelitis was performed using the expedium viper system.The fixed area was l2 ¿ s2.During the surgery, the surgeon confirmed the following issues.He tried to tighten the screw (part#:179704890, lot#: tbfnl) with a driver (part# & lot#: unk).He heard the screw span at the time of tightening.He decided to replace it with a new screw because he felt that the head of screw might be a bit stripped.The surgery was successfully completed with a 5-minute delay, and there was no adverse consequence to the patient.After the surgery, the surgeon and our sales rep confirmed that inner part of the screw head was stripped.
Additional Manufacturer Narrative
Upon completion of the investigation, it was determined that there was no product problem identified with the returned device.The device did not strip as originally reported.As a result, the complaint is no longer a reportable malfunction.This follow up serves as awareness to the change in reportability of the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER
• 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: 6871761
• Report Number: 1526439-2017-10745
• Device Sequence Number: 1297628
• Product Code: NKB
• UDI-Device Identifier: 10705034265742
• UDI-Public: (01)10705034265742
• 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): 08/23/2017

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 Model Number: 179704890
• Device Catalogue Number: 179704890
• Device Lot Number: TBFNL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 09/18/2017
• Supplement Report FDA Received Date: 10/05/2017
• Patient Sequence Number: 1