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 Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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
The following was reported: the surgery was going well with mountaineer instruments and implants until we got to the cross link portion, towards the end of the case.The surgeon placed the cross link set screw in the head of the favored angle screw and final tightened like it suggests in the technique.He then chose a cross link to fit over the cross link set screw, and started driving a hex nut with the hex nut driver down clockwise until hand tight.He then grabbed the hex nut driver and the final tightener drive, both with grey handles, and started to lock the nut with the hex nut driver.Before he was able to final tighten he noticed that the threads of the set screw earlier placed were shearing off as he drive the hex nut driver down.He replaced set screw and repositioned cross link and tried to drive a hex nut down a total of 4 times and it happened all 4 times? he followed the technique guide exactly.He decided to not use the cross link due to this issue so he took out/explanted cross link set scores, cross link, and all hex nuts.Replaced the cross link set screws with regular set screws and locked down construct.The only thing that i could think of was that the hex nut driver looked to have a damaged thread inside the instrument.Would like someone to examine the hex nut driver.A 10 minute surgery delay was also reported.

• 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: 8355680
• Report Number: 1526439-2019-51372
• Device Sequence Number: 16736973
• Product Code: NKG
• UDI-Device Identifier: 10705034158679
• UDI-Public: (01)10705034158679
• Combination Product (Y/N): N
• Initial Reporter State: KY
• PMA/510(K) Number: K042508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/27/2019

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
• Device Lot Number: BDK3TWP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2019
• Initial Report FDA Received Date: 02/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other