MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNITIZED DI SET SCW, TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	179722050
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	07/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Visual examination of the unitized di set scw, ti has exhibited significant signs of clinical use.It was noted that the unitized set screw is cross-threaded into the tulip heads with a piece of rod stuck in the tulip head.The reported compliant of torn threads on the unitized set screw cannot be confirmed from the given information.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.A definitive root cause cannot be determined for the cross-threading of the set-screw and jamming in the poly-axial screw threads.A potential root cause could be due to inadvertently cross-threading the set screw with the screw during the insertion and subsequent attempts to tighten the set screw, placing enough force on the threads to tear them off completely.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.
Event or Problem Description
On (b)(6) 2018, the tlif surgery for lumbar spondylolisthesis was performed by using the expedium system.The fixed site was l5 ¿ s1.During the surgery, due to an excessive inserting torque, the tip of the driver ((b)(4)) got broken and the broken tip was left in the head of the screw (either (b)(4)), which resulted in the insertion failure.The screw in question was extracted and then a new screw was inserted.No broken pieces were found left in the patient¿s body under the x-ray.The surgery was successfully completed with a 60-minute delay, and there was no adverse consequence to the patient.The surgeon has requested us to make an in-depth investigation including a possibility of metallic fatigue.

• Brand Name: UNITIZED DI SET SCW, TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 7847684
• Report Number: 1526439-2018-50847
• Device Sequence Number: 1468699
• Product Code: NKB
• UDI-Device Identifier: 10705034070087
• UDI-Public: (01)10705034070087
• Combination Product (Y/N): N
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2018

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: 179722050
• Device Catalogue Number: 179722050
• Device Lot Number: SP1004199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 09/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1