MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 4.35 X 30; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	199721430
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4), unknown.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
It was reported that on an unknown date, during scoliosis surgery a screw was broken on a t10-l2 cobalt com rod.Screw was removed and was replaced, procedure and patient outcome are unknown.This complaint involves one (1) device.
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 returned device found the assembly was broken at the end of the screw head base.The proximal end of the device has broken off and no fragments were returned.There are clear shear marks at the fracture site.The inner threads at the fracture site appear to be stripped/deformed.The expedium verse cap and ring appear to have no visible defects.The poly-screw¿s head has scratches and nicks consistent with wear.The poly-screw¿s head is also discolored.These cosmetic issues are likely caused by friction the screw experiences while rotating in the assembly.The poly screw threads appear to be dull and worn, this may have occurred during explantation.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.Although no definitive root cause could be determined, it is possible that the device encountered unintended forces during implantation such as over-torque.There was no indication that a design or manufacturing issue contributed to the complaint.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, 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: 5.5 EXP VERSE SCREW 4.35 X 30
• 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: 8718341
• Report Number: 1526439-2019-51775
• Device Sequence Number: 1860137
• Product Code: NKB
• UDI-Device Identifier: 10705034442648
• UDI-Public: (01)10705034442648
• Combination Product (Y/N): N
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2019

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: 199721430
• Device Catalogue Number: 199721430
• Device Lot Number: ATNBJN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 63