MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186731750
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional device product codes: (b)(4).Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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
It was reported that on (b)(6) 2021, the surgeon used custom awls to access the pedicle, and then inserted the 7.0x50mm cortical fix screw at l5 on the right side.As the screw was being inserted the tulip head popped off disengaging from the body of the screw.The surgeon attempted to remove the body of the screw with a t20 driver but stripped the t20 cannulated driver.The surgeon also stripped the t20 non cannulated driver and fractured the tip of the mini open driver.The broken tip of the mini open driver was possibly inside the hex of the screw.The next attempt to remove the shaft of the screw was to use a screw removal reverse thread instrument, which failed to remove the screw.The surgeon was able to successfully remove the fractured instrument and confirmed with both x-ray and matching it up, that the instrument was removed.The screw remained in the patient with a rescue screw 5.0x50mm placed directly beside it.To insert the rescue screw, the surgeon used a jam shidi, and guide wire with 4.35mm tap.The rescue screw had no issue, and the surgeon was able to pass the rod and finish up.The tulip was recovered, the shaft of the 7.0x50mm screw remains in the patient, the tip of the mini hex driver is missing, and the fragment from the screw removal set was removed and accounted for.There was a surgical delay of estimated thirty (30) to forty-five (45) minutes.Patient status is unknown.The procedure was successfully completed.This report involves one (1) viper system cortical fix polyaxial screw 5.5 7 x 50mm.This is report 1 of 4 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.Visual inspection: the 5.5 ti cort fix 7x50mm (part#: 186731750, lot#: 198093) was returned and received at us cq.Upon visual inspection, it was observed that the rod was broken off the head and the broken piece was not returned to the us cq.The embedded piece cannot be confirmed as there was no evidence (photos or x-rays) provided showing that the fragments were embedded in the patient.No other issues were identified with the returned device.Document/specification review: based on the date of manufacture the relevant drawings, the current and manufactured revision of drawings were reviewed.Dimensional inspection: the dimensional inspection was not performed due to no access to relevant components.Investigation conclusion: the complaint condition is confirmed for the 5.5 ti cort fix 7x50mm (part#: 186731750, lot#: 198093) as the device received was broken.However, the embedded device allegation was not confirmed as there were no photos or x-rays provided.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to unintended forces applied to the device.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.H3, h4, h6: a device history record (dhr) review was conducted: part#: 186731750, lot#: 198093.The dhr of product code: 186731750, lot: 198093, was reviewed and no non-conformances were observed during the manufacturing process.The product was released on may 18, 2018.Qty.99.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: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 7 X 50MM
• 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: 11666047
• Report Number: 1526439-2021-00715
• Device Sequence Number: 16926136
• Product Code: MNH
• UDI-Device Identifier: 10705034352022
• UDI-Public: (01)10705034352022
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 186731750
• Device Catalogue Number: 186731750
• Device Lot Number: 198093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/14/2021
• Supplement Report FDA Received Date: 05/13/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REMOVAL INSTRUMENT.; T20 SCREWDRIVER SHAFT.; UNKNOWN AWLS.; UNKNOWN GUIDE/COMPRESSION/K-WIRES.; UNKNOWN RODS.; UNKNOWN SPD PRODUCT.; VIPER UNIVERSAL POLY DRIVER.; VIPER2 T20 HEXLOBE DRIVER SHAF.
• Patient Age: 59 YR