MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 40; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	199721640
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: kwp; kwq; mnh; mni; osh.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2020 the patient underwent for an unknown surgery.During the surgery, the screw has inner thread damaged due to multiple trying to engage correction key while the correction key has the inner grey part isn¿t locked.It was unknown if the surgery completed successfully.The patient outcome unknown.This complaint involves seven (7) devices.This report is for (1) 5.5 exp verse screw 6.0 x 40.This report is 1 of 7 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: d11: concomitant product added to complaint.Investigation summary background: 1.Screw damage due to correction key damage 2.Inner grey part isn't locked.11/11/2020 updated event description: this complaint involves seven (7) devices.11/19/2020 updated event description: the screw has inner thread damaged due to multiple trying to engage correction key while the correction key has the inner grey part isn¿t locked.Investigation flow: device interaction/functional.Visual inspection: the 5.5 exp verse screw 6.0 x 4.0 (p/n: 199721640, lot #: 224314) was returned and received at us cq.Upon visual inspection, it was observed that the head of the screw was locked in the monoaxial position.Per the system guide dsus/spn/0115/0747(1), the polyaxial screw converts to a monoaxial screw upon tightening of the set screw.The system guide indicates that exceeding the system torque may result in failure of the implant.Upon loosening of the set screw, the screw head should become mobile again.Functional test: a functional assessment was performed on the complaint device.The head of the screw was unable to be moved from the received position.The returned verse correction keys (p/n: 199721000, lot #: 206341) was able to assemble to the verse screw.The verse correction key is being investigated in a different (b)(4).Can the complaint can be replicated with the returned device.Dimensional inspection: the outer diameter of the screw head was measured to be within the specification.Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed.Dwg-887046545, rev b/a.Dwg-887042533, rev: a.Dsus/spn/0115/0747(1).No design issues or discrepancies were identified.Complaint was confirmed.Investigation conclusion: the complaint condition is confirmed for the 5.5 exp verse screw 6.0 x 4.0 (p/n: 199721640, lot #: 224314).There is no indication that a design or manufacturing issue has caused the complaint condition and the possible root cause is over-torqueing of the set screws, however no definitive root cause could be identified.Based on the investigation findings, it has been determined that 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.
Additional 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.H10 additional narrative: h3, h4, h6- the complaint condition is confirmed for the 5.5 exp verse screw 6.0 x 4.0 (p/n: 199721640, lot #: 224314).There is no indication that a design or manufacturing issue has caused the complaint condition and the possible root cause is over-torqueing of the set screws, however no definitive root cause could be identified.Based on the investigation findings, it has been determined that 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 history lot: the dhr of product code: 199721640.Lot : 224314.Was electronically reviewed and the non-conformance nr-0112669.Has been observed during the manufacturing process, sorting done as part of the nr guaranty the product quality.The product was released on: 26.11.2018.Device history batch: null.Device history review: null.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.

• Brand Name: 5.5 EXP VERSE SCREW 6.0 X 40
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10945390
• Report Number: 1526439-2020-02350
• Device Sequence Number: 19509554
• Product Code: NKB
• UDI-Device Identifier: 10705034442280
• UDI-Public: 10705034442280
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/09/2020

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: 199721640
• Device Catalogue Number: 199721640
• Device Lot Number: 224314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/28/2021; 02/02/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/29/2021; 02/03/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 EXP VERSE SCREW 6.0 X 40; 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 6.0 X 45; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; 5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 6.0 X 45; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY