MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MNTR H/H X-CONN INNER SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	188341200
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
When the surgeon was doing final tightening with torque drivers the locking screw and the nut jumped out.Patient consequence? :no.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination of the returned device showed signs of operative use as evidenced by superficial markings, with significant damage to the threads of the inner screw.It was noted that the inner set screw has its threads peeled while the inner screw drive feature is slightly damaged.The exact lot number was not legible from the set screw received; therefore, the manufacturing or receiving inspection records could not be reviewed.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.A potential root cause may be cross-threading and damaging thread during insertion.Tightening the set screw while it is cross threaded places an unexpectedly high amount of force on the threads both the inner and outer set screw threads.This can potentially result in damage and/or tearing to the threads of both the set screw and poly-axial 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 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 H/H X-CONN INNER SCREW
• 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: 7680965
• Report Number: 1526439-2018-50642
• Device Sequence Number: 1528245
• Product Code: NKG
• UDI-Device Identifier: 10705034158679
• UDI-Public: (01)10705034158679
• Combination Product (Y/N): N
• PMA/510(K) Number: K042508
• 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): 02/14/2018

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: 188341200
• Device Catalogue Number: 188341200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/12/2018
• 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