MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS TI CFX FEN POLY 7X45; BONE CEMENT, POSTERIOR SCREW AUGMENTATION

Model Number	186727745
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	09/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report 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
It was reported an l3-s1 mis tlif + posterior instrumented fusion: (b)(6); (b)(6) hospital (b)(6) 2018.Whilst trying to seat the rod, surgeon was unable to reduce set screw into head of tulip.Tried multiple times.Surgeon requested x-ray.On x-ray it was apparent that the tulip had disengaged from shank of screw.Surgeon was able to release tulip from extension tube.Shank of screw was backed out by t20 driver in expedium kit.This took 2 hours, additional time for patient under anaesthesia.Surgeon would like device report as to this lot number to minimise risk to other patients.Not a desirable outcome for his patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi:(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination of the mis ti cfx fen poly 7x45 revealed that the screw head was disassembled from the shank, with saddle intact in the screw head and drive feature on the shank is significantly worn.It was also noted that the flex ball in the screw head was partially damaged.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 cannot be determined from the sample and the information provided.A potential root cause may be 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 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: MIS TI CFX FEN POLY 7X45
• Common Device Name: BONE CEMENT, POSTERIOR SCREW AUGMENTATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7922423
• Report Number: 1526439-2018-50928
• Device Sequence Number: 1472984
• Product Code: PML
• UDI-Device Identifier: 10705034282671
• UDI-Public: (01)10705034282671
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2018

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: 186727745
• Device Catalogue Number: 186727745
• Device Lot Number: ARJDKD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 10/01/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1