MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE SCREW 6.0 X 45; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	199721645
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional device product codes: nkb, kwq, kwp, mnh, osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during a spine revision surgery, the head of the verse screws did not become poliaxial and the screwdriver could not be inserted to take out the screws.The locking screws and rods were removed.Another instrument was used to remove to remove the screws.There was a surgical delay of twenty (20) minutes.No fragments were generated.The procedure was completed successfully.There were no consequences to the patient.Concomitant device reported: rods (part number unknown, lot unknown, quantity unknown), locking screw/ set screw (part number unknown, lot unknown, quantity unknown), 5.5 exp verse screw 6.0 x 45 (part number 199721645, lot 269766, quantity 2), 5.5 exp verse screw 6.0 x 45 (part number 199721645, lot 218140, quantity 1), 5.5 exp verse screw 6.0 x 45 (part number 199721645, lot 240964, quantity 1), 5.5 exp verse screw 6.0 x 40 (part number 199721640, lot 226103, quantity 1), 5.5 exp verse screw 6.0 x 40 (part number 199721640, lot 256371, quantity 1), screwdriver (part number unknown, lot unknown, quantity 1).This report involves one (1) expedium verse spine system polyaxial screw 5.5 6.0 x 45mm.This is report 4 of 8 for (b)(4).
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.H3, h6: a product investigation was conducted: investigation flow: functional/device interaction.Visual inspection: the 5.5 exp verse screw 6.0 x 45 (p/n: 199721645, lot number: 269766) was received at us cq.Visual inspection of the complaint device showed 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 complaint was able to be replicated.Dimensional inspection: a dimensional inspection was not performed since it was not applicable to the complaint condition.Document/specification review: no design issues or discrepancies were identified.The complaint was confirmed.Investigation conclusion: this complaint is confirmed as the screw head is unable to move.A possible root cause is over-torquing of the set screws, however no definitive root cause could be identified.There was no indication that a design or manufacturing issue contributed to the complaint.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 199721645, lot 269766, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on january 27, 2020.Qty.428.The dhr was electronically reviewed.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 45
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 10540290
• Report Number: 1526439-2020-01701
• Device Sequence Number: 19623517
• Product Code: MNI
• UDI-Device Identifier: 10705034442273
• UDI-Public: (01)10705034442273
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K142185
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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: 199721645
• Device Catalogue Number: 199721645
• Device Lot Number: 269766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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 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; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWDRIVERS; 5.5 EXP VERSE SCREW 6.0 X 40; 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; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWDRIVERS
• Patient Age: 79 YR