MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 7X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731750
Medical Device Problem Codes	Disconnection (1171); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).5.5 ti cort fix 7x50mm was returned for evaluation.Visual examination of the returned screw reveals signs of operative use as evidenced by superficial markings, with its threads completely peeled off on the shank and damage to the drive feature.It was also noted that the flex ball on the screw head is broken into pieces and a piece of rod and set screw was struck in the head.Exerting a significant amount of force on the tulip head and saddle, potentially at a significant angle, may be sufficient to dislodge the saddle.A device history record review did not find any issues that could have caused or contributed to the reported event.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.With the information provided, a definitive root cause for the torn threads on the 5.5 ti cort fix 7x50mm and falling apart of the screw intraoperatively cannot be determined.A potential root cause for falling apart of the shank and the flex ball 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 no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.A such, the complaint 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
It was reported the posterior lumbar fusion surgery was performed on (b)(6) 2018 to fix l4 with under -6mm tapping.During the surgery, the surgeon felt the difficulty to insert the screw since the patient has the strong bone quality.Then, it was reported that the driver tip was broken with the clicking sound when the surgeon inserted the screw into the patient¿s bone.The surgeon removed all broken fragment from the patient¿s body.The surgery was completed by using 7 x 45mm screw into the same bone hole.There was less than 30min.Surgical delay and there was no adverse consequence to the patient.No further information was provided by the hospital.

• Brand Name: 5.5 TI CORT FIX 7X50MM
• 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: 8080920
• Report Number: 1526439-2018-51076
• Device Sequence Number: 11185512
• Product Code: NKB
• UDI-Device Identifier: 10705034352022
• UDI-Public: (01)10705034352022
• Combination Product (Y/N): N
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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: 186731750
• Device Catalogue Number: 186731750
• Device Lot Number: 171267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1