MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER POLY SCREW 8X50MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186715850
Medical Device Problem Code	Disassembly (1168)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation 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
It was reported doctor was implanting 8x50 viper screw.He stopped to take fluoro picture to confirm all was ok with placement.Started to advance screw further down and screw head popped off.The ring between screw head and screw shank was broken.Had to retrieve those broken metal fragments and take screw shaft out.Fifteen minutes delay reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the viper poly screw 8 x 50mm ti revealed that the screw head was disassembled from the shank, with broken saddle intact in the screw head.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the screw falling apart intraoperatively cannot be determined from the sample and the information provided.A potential root cause may be inadvertent force 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 were found, 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: VIPER POLY SCREW 8X50MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7432336
• Report Number: 1526439-2018-50358
• Device Sequence Number: 10799269
• Product Code: NKB
• UDI-Device Identifier: 10705034122755
• UDI-Public: (01)10705034122755
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2018

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: Health Professional
• Device Model Number: 186715850
• Device Catalogue Number: 186715850
• Device Lot Number: RL260178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Initial Date Received by Manufacturer: 03/19/2018
• Supplement Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR