MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE UNITIZED SET SCR; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 199721001

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2018

Event Type  Injury  

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 Description

It was reported that during this case, the surgeon completed final tightening all implanted verse screws.Upon breaking off the reduction tabs, he noticed one unitized set screw didn't make into the screw head and came off with the reduction tabs.He then used the reduction devices (2997-04-270, 2997-04-272, 2997-04-275) to help seat the set screw into the verse screw head.The reduction devices were used properly.He immediately noticed that the set screw was cross treading.The reduction device was reduced completely to the point where the reducer handle wouldn't turn.The surgeon removed the device and verified that set screw was cross threaded.The surgeon then asked for verse's newest 3 piece reduction device (2997-04-306) along with a new unitized set screw,.Again, the devices were used properly.The same problem occurred.This problem has occurred in 2 cases prior to this day.Was surgery delayed due to the reported event? yes.If yes, number of minutes: 30.Action taken when event occurred? removal and replacement of screw.Was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? yes.Patient status/ outcome / consequences no.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? unknown.Is the patient part of a clinical study? unknown.

Manufacturer Narrative

(b)(4).Visual examination of the returned device noted that a large section of the set screw¿s thread had been torn from the side of the body of the set screw.This section is not broken off from the rest of the thread, but is simply torn from the side of the body of the set screw.T 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.The root cause of the set screw thread tearing cannot be determined from the sample and the information provided.A potential root cause may be inadvertently cross threading the set screw during insertion and tightening.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: 5.5 EXP VERSE UNITIZED SET SCR
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8223525
• MDR Text Key: 132371117
• Report Number: 1526439-2019-51206
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466156
• UDI-Public: (01)10705034466156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721001
• Device Catalogue Number: 199721001
• Device Lot Number: VL1223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other