MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR F/A SCREW 3.5X16; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188318316
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
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
It was reported that this was a psf (posterior spinal fusion) procedure (c4) treating csm (cervical spondylotic myelopathy) on (b)(6) 2019.It was difficult to tighten a setscrew during rod fixation.When the surgeon removed a rod, s/he found that some inner areas of the screw¿s head (188318316) where the rod was supposed be placed had been extruded.The procedure was completed with a replacement less than a 30-minute surgical delay.No further information is available.Concomitant devices reported: unknown rod (part#: unknown, lot#: unknown, quantity: 1).This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.
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 revealed signs of operative use as evidenced by superficial markings.The inner cap (saddle) is dislodged from its intended location.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 the screw falling apart cannot be determined from the sample and the information provided.A potential root cause 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 from its intended location 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, 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: MNTR F/A SCREW 3.5X16
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9146500
• Report Number: 1526439-2019-52185
• Device Sequence Number: 16844613
• Product Code: NKG
• UDI-Device Identifier: 10705034157191
• UDI-Public: (01)10705034157191
• Combination Product (Y/N): N
• PMA/510(K) Number: K041203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2019

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: 188318316
• Device Catalogue Number: 188318316
• Device Lot Number: 250620
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 12/03/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 11/01/2019; 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1