MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL EXT TAB 6 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179732645
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The 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
Expedium 5.5 titanium screws.1797-32-645 - 4 pieces.Reason for contact: intraoperatively, while tightening the reduction screw with a nut-screw, the tuning forks of the two screws prematurely broke off.The incident was reported to the operating surgeon.Date / time of the incident: (b)(6) 2019 13:00.Date / time when j & j employee became aware of the incident: july 15, 2019 13:00.Photos of products attached.
Additional Manufacturer Narrative
Product complaint # (b)(4).Udi: (b)(4).Report type: corrected data.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.Device was not returned for evaluation.A review of the device history record could not be performed as the lot number is unknown.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.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
Expedium 5.5 titanium screws: 1797-32-645 - 4 pieces.Reason for contact: intraoperatively, while tightening the reduction screw with a nut-screw, the tuning forks of the two screws prematurely broke off.The incident was reported to the operating surgeon.Date / time of the incident: (b)(6) 2019 13:00.Date / time when j & j employee became aware of the incident: july 15, 2019 13:00.Concomitant device reported: si polyaxl ext tab 6 x 45mm (part# 179732645, lot# unknown, quantity 2).This complaint involves two (2) devices.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• Brand Name: SI POLYAXL EXT TAB 6 X 45MM
• 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: 8865408
• Report Number: 1526439-2019-51937
• Device Sequence Number: 14276556
• Product Code: NKB
• UDI-Device Identifier: 10705034073873
• UDI-Public: (01)10705034073873
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2019

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: 179732645
• Device Catalogue Number: 179732645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019; 09/30/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/08/2019; 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1