MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 TI CORT FIX 8X50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	186731850
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
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
It was reported that this was a plif (posterior lumbar interbody fusion) procedure treating spinal stenosis with l4-5 stabilization on (b)(6) 2019.While the surgeon was inserting the screw (186731850) with the screwdriver (279751002) up to approximately 25mm into the l5 left, s/he felt excessive torque and was not able to insert it further.Although the surgeon tried to retract the screw, s/he encountered another excessive torque and found that the screwdriver¿s tip had been broken off.During the troubleshooting, the surgeon saw metal particles around the screw¿s head.While those particles were being removed, the screwhead came off, leaving the bone screw in the bone.The fragmented screwdriver¿s tip remains in the patient¿s body, too.It was confirmed by imaging that the metal particles had been removed.The procedure was delayed for 60 minutes.No further information is available.This complaint involves two (2) 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.The tulip head and broken fragments of flex ball were returned.The screw shank was not returned.The returned tulip head features signs of use.The flex ball had fractured this allowed the saddle and tulip head to separate from the screw shank.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.The root cause of flex ball becoming fractured cannot be determined from the sample and the information provided.A potential root cause may be excessive force placed on the polyaxial screw¿s flex ball, especially at an extreme angle in relation to the adjacent components of the screw.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 TI CORT FIX 8X50MM
• 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: 9122596
• Report Number: 1526439-2019-52157
• Device Sequence Number: 19439273
• Product Code: NKB
• UDI-Device Identifier: 10705034352206
• UDI-Public: (01)10705034352206
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 186731850
• Device Catalogue Number: 186731850
• Device Lot Number: AVLBCD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1