MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR M/L SCREW 3.5 DIA X 26; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188319326
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).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 emergency surgery for dislocation fracture at c7 was performed by using the mountaineer spine system.During the surgery, at the time of set screw insertion, it was found that the internal head of the screw (188319326) was cross-threaded.The surgeon tried to tighten the screw in question with another new set screw, but he could not tighten it.As he noticed that the head of the screw in question was broken, he extracted the broken pieces from the patient¿s body and replaced the screw in question with another same size of the screw.The surgery was successfully completed, but it was delayed within 30 minutes due to this event.No broken pieces were found left in the patient¿s body, and there was no adverse consequence to the patient.While the surgeon is concerned about deterioration of the product, he is requesting us to investigate on the root cause of this event.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device revealed signs of operative use as evidenced by superficial markings, with its threads completely peeled off and damage to the drive feature of the screw head.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.With the information provided, a definitive root cause cannot be determined.This damage may have potentially occurred due to cross-threading a set screw upon insertion.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.

• Brand Name: MNTR M/L SCREW 3.5 DIA X 26
• 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: 7637685
• Report Number: 1526439-2018-50589
• Device Sequence Number: 2482292
• Product Code: NKG
• UDI-Device Identifier: 10705034157689
• UDI-Public: (01)10705034157689
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2018

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: 188319326
• Device Catalogue Number: 188319326
• Device Lot Number: 123907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Initial Date Received by Manufacturer: 06/02/2018
• Supplement Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other