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

Model Number	188341200
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
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
In a posterior cervical c2-c4 fusion dr.(b)(6) attempted to final tighten the 188341200 tall set screw on the long shank screw 188320328 and it would not tighten; just spinning and not engaging the screw threads.Multiple different 188341200 set screws were used but none threaded.It was unknown but possible the torque was out of calibration and damaged the screw.The affected 188320328 screw and several of attempted tall set screws with nuts 188341100 and 188341200 are being returned for investigation as well as all torque drivers to ensure patient safety.There was also a 188341028 cross connector at this level but was unlikely to have caused the problem.The surgery finished without further incident after new trays were opened and a 188320328 screw was placed.Replacement p.O.For instruments 7400049279.Patient consequence? :no.Patient consequence description:delay in surgery to acquire replacement instruments and implants.Action taken for procedure:new trays opened.Is the information being submitted for this complaint all the details that are known/available regarding this event?: yes.
Additional Manufacturer Narrative
(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 which is stuck inside the outer 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 during 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 H/H X-CONN INNER SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7318370
• Report Number: 1526439-2018-50206
• Device Sequence Number: 13480176
• Product Code: KWP
• UDI-Device Identifier: 10705034158679
• UDI-Public: (01)10705034158679
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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: 188341200
• Device Catalogue Number: 188341200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 02/16/2018
• Supplement Date Received by Manufacturer: 04/16/2018; 06/27/2018
• Initial Report FDA Received Date: 03/06/2018
• Supplement Report FDA Received Date: 05/02/2018; 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1