MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR M/L SCREW 4.0 DIA X 22; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188319422
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	04/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
On (b)(6) 2018, the surgery for unknown reasons was performed using the mountaineer spine system.The fixed area was c7 (right).During the surgery, the following event was confirmed by the surgeon.He inserted the reported screw ((b)(4)) to c7 (right) after attaching this screw to the screwdriver.He temporarily felt difficulties pulling out the screwdriver, but he could do it.When placing the rod, he noticed that the head of the screw was broken.He extracted the broken screw and replaced it with a new one.The surgery was successfully completed with a less-than-30-minute delay, and there was no adverse consequence to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the screw revealed that the inner cap (saddle) is dislodged to a certain degree 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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.The root cause of the mountaineer 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 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 and no systemic trends were found, 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.
Additional Manufacturer Narrative
Product complaint #: (b)(4).

• Brand Name: MNTR M/L SCREW 4.0 DIA X 22
• 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: 7482843
• Report Number: 1526439-2018-50450
• Device Sequence Number: 1592031
• Product Code: NKG
• UDI-Device Identifier: 10705034157887
• UDI-Public: (01)10705034157887
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/17/2018

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: 188319422
• Device Catalogue Number: 188319422
• Device Lot Number: ALHC6H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/31/2018; 05/31/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/04/2018; 06/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1