MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 6X35MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186731635
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the screw revealed that the inner cap (saddle) is loosened to a certain degree from its intended location.Also, the screw has significant indentation marks and worn threads from the operative usage.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 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 saddle falling apart 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.
Event or Problem Description
On (b)(6) 2018, the surgery for thoracic posterior fixation was performed for by using the expedium plus spine system.During the surgery, the surgeon had an uncomfortable feeling with the screw (186731635, lot#: 190598) when he was trying to attach it to a screw driver (part#: unk).Then he tried to detach it from the screw driver, but it could not be detached at all.The surgery was successfully completed with a less-than-30-minute delay, and there was no adverse consequence to the patient.No further information has been provided.

• Brand Name: 5.5 TI CORT FIX 6X35MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7691163
• Report Number: 1526439-2018-50688
• Device Sequence Number: 11016723
• Product Code: KWQ
• UDI-Device Identifier: 10705034351810
• UDI-Public: (01)10705034351810
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: 186731635
• Device Catalogue Number: 186731635
• Device Lot Number: 190598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1