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

Model Number 199721001

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/ investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from depuy spine reports an event in (b)(6) as follows: it was reported that in the course of the treatment of a scoliosis, problems occurred during the placement of a pedicle screw with a locking screw.After successful implantation of various pedicle screws, the rod was placed.For this purpose, a rod was cut to size, pre-bent accordingly, inserted into the screw heads and temporarily fixed with end caps (partly single, partly dual).Finally, the caps were tightened with torque.It was noticed that on one screw in a segment that was distracted and compressed, the dual innie did not release the required torque.In the correct sequence, the outer part of the closure cap was first tightened with torque.When the inner portion was subsequently attempted to be tightened, no torque could be released.Instead, the inner part spun in the outer part of the dual-innie.Another dual innie was then used, unfortunately with the same result.A subsequent single innie also did not produce the desired result, this one spinning in the screw head before the torque was triggered.It can therefore assumed that the problem is related to the thread of the screw head.Unfortunately, the lot number of this screw was not readable in situ.At this point, all reduction maneuvers had already been carried out and the rod had been fixed in large part, so changing the screw was no longer an option for the user at this point of the operation.Since, according to the user, there was sufficient stability in the construct, it was decided to leave the screw in place and complete the procedure.The surgery was delayed for fifteen (15) minutes due to the reported event.The procedure was successfully completed.This report is for one (1) expedium verse spine system unitized set screw 5.5.This is report 4 of 4 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the device history record (dhr) of product code: 199721001 lot : xp1323 was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: february 18, 2021 visual inspection: the 5.5 exp verse unitized set scr was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the outer threads of the device were stripped.No other issues were found with the device.Functional test: functional testing was not performed at cq as the device was received by itself and the mating devices were not returned.Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to it being post manufacturing damage.Document/specification review: the following drawing(s) was reviewed: - expedium verse - single lock (current and manufactured to) no design issues or discrepancies were found during this investigation.Investigation conclusion: the complaint is being confirmed for the 5.5 exp verse unitized set scr as the outer threads of the device were stripped and could have caused the complaint condition.A definitive root cause could not be identified for the reported issue from the available information.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based upon these results, no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.D9.

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5
• 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 Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12795852
• MDR Text Key: 282637157
• Report Number: 1526439-2021-02369
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034466156
• UDI-Public: (01)10705034466156
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721001
• Device Catalogue Number: 199721001
• Device Lot Number: XP1323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE UNITIZED SET SCR; UNKNOWN END CAPS; UNKNOWN RODS; UNKNOWN TORQUE DEVICES; VERSE CORRECTION KEY; VERSE CORRECTION KEY
• Patient Age: 28 YR
• Patient Sex: Female