MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 7.0 X 55; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 199721755

Device Problems Break (1069); Device-Device Incompatibility (2919); Mechanical Jam (2983)

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

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: kwp; kwq; mnh; mni; osh complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: reporter is a j&j sales representative.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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a patient was treated with exp verse due to a deformation of the spine from t4-l4.During the first part correction a rod was placed at the lower part and the screws were fixated with a verse correction key through which a mono-axiality was created.The verse correction keys were not tightened with a torque limited but only tightened softly by hand to normal soften tightening of the rod without final locking.After loosening the verse correction keys the mono-axiality was not revoked and the mono-block continued to exist.No de-rotation was performed until then.The l4 exp verse 7mm pedicle screw broke through and all screws needed to be replaced with bigger screws as the pedicle fracturing caused all 4 screws become locked mono-axial characteristics after removing the temporary rod.There was surgical delay of forty (40) minutes due to the reported event.Procedure was completed successfully.This report is for one (1) 5.5 exp verse screw 7.0 x 55.This is report 1 of 5 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.H3, h4, h6: the device history record (dhr) of product code 199721755, lot 230116, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on october 14, 2019.H3, h6: a photo investigation was completed: the device was not returned.A photo-investigation was performed on the provided images.A broken reduction tab was observed.No other product issues were observed.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The complaint was confirmed during investigation.No device malfunction, damage, or defect was noted during investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.A product investigation was conducted.Visual inspection: the 5.5 exp verse screw 7.0 x 55 (p/n: (b)(4), lot number: 230116) was received at us cq.Visual inspection of the complaint device showed that the screw shank (part # 887046465) was discolored.Scratches were also observed on the expedium verse screw head (part # 887042533).The screw shank was not able to rotate around the screw head which is expected per the design of the device after it has been used.Also the extended tabs were broken off from the screw head.Functional test: a functional assessment was not performed with the complaint device since the applicable mating component(s) were not returned.Dimensional inspection: no dimensional inspection was performed due to requiring destruction of the device, and device assembly and geometry limits ability to accurately dimensionally inspect document/specification review: based on the date of the release to the warehouse the relevant current and manufactured drawings were reviewed.No design issues or discrepancies were identified.Investigation conclusion: the overall complaint could be confirmed as the device that was returned showed the two extended tab being broke off.Per design these are supposed to be broken off before completing the surgery but it looks like in this case the extended tab breakage was not intentional thus the complaint is confirmed.Also the screw shank was stuck and unable to rotate; this condition is expected per design of the device and unlocking the screw would require the use of correction key.However scratches noted on the screw were due to the device being used.The discoloration noted could not contribute to the reported condition.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.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 on the investigation findings, it has been determined that no corrective and/or preventive 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.

• Brand Name: 5.5 EXP VERSE SCREW 7.0 X 55
• 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
• MDR Report Key: 10906304
• MDR Text Key: 223612046
• Report Number: 1526439-2020-02290
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034442082
• UDI-Public: (01)10705034442082
• Combination Product (y/n): N
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 199721755
• Device Catalogue Number: 199721755
• Device Lot Number: 230116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Date Manufacturer Received: 02/18/2021
• Patient Sequence Number: 1
• Treatment: 5.5 EXP VERSE SCREW 6.0 X 50; 5.5 EXP VERSE SCREW 6.0 X 50; 5.5 EXP VERSE SCREW 6.0 X 50; 5.5 EXP VERSE SCREW 6.0 X 50; UNKNOWN RODS; UNKNOWN TORQUE LIMITER; VERSE CORRECTION KEY
• Patient Age: 61 YR
• Patient Weight: 70