MAUDE Adverse Event Report: SYNTHES GMBH 4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Model Number	04.615.126
Medical Device Problem Code	Compatibility Problem (2960)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2022
Type of Reportable Event	Malfunction
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.Procode: mnh, kwp, mni.Device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The initial reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 japan reports an event as follows: it was reported that on (b)(6) 2022, during o-t fusion (cervical spine) for cervical myelopathy, the screw in question could not be attached to the two screwdrivers in question.The operation was completed successfully using another synapse screwdriver.There was a delay of approximately 30 minutes.This report is for a 4.0mm ti cancellous polyaxial screw 26mm for 4.0mm rods.This is report 1 of 7 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects on the surface of cancellousscr synapse ø4 l26 f/r ø4 tan, p/n: 04.615.126s.A dimensional inspection was unable to be performed due to not being relevant to the complaint condition.A functional test was performed.The outer sleeve was assembled to the returned hexagonal screwdriver shaft cross pinned, p/n: 03.614.039, and the returned hold-sl, p/n: 03.614.017.After that, the returned cancellousscr synapse ø4 l26 f/r ø4 tan, p/n: 04.615.126s, was threaded to the assembly.The screw was successfully assembled.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the cancellousscr synapse ø4 l26 f/r ø4 tan, p/n: 04.615.126s would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.If information is obtained that was not available for this 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.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that there was no damage or defects on the surface of cancellousscr synapse ø4 l26 f/r ø4 tan, p/n: 04.615.126s.A dimensional inspection was unable to be performed due to not being relevant to the complaint condition.A functional test was performed.The outer sleeve was assembled to the returned hexagonal screwdriver shaft cross pinned, p/n: 03.614.039, and the returned hold-sl, p/n: 03.614.017.After that, the returned cancellousscr synapse ø4 l26 f/r ø4 tan, p/n: 04.615.126s, was threaded to the assembly.The screw was successfully assembled.The complaint condition was not replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the cancellousscr synapse ø4 l26 f/r ø4 tan, p/n: 04.615.126s would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed? yes, reviewed dimensional inspection: n/a device history a manufacturing related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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: 4.0MM TI CANCELLOUS POLYAXIAL SCREW 26MM FOR 4.0MM RODS
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15463446
• Report Number: 8030965-2022-07194
• Device Sequence Number: 6873957
• Product Code: NKG
• UDI-Device Identifier: 10705034740010
• UDI-Public: (01)10705034740010
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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: 04.615.126
• Device Catalogue Number: 04.615.126S
• Device Lot Number: 55P2341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/02/2022
• Supplement Date Received by Manufacturer: 10/05/2022; 11/28/2022
• Initial Report FDA Received Date: 09/22/2022
• Supplement Report FDA Received Date: 10/28/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HEXAGONAL SCREWDRIVER SHAFT CROSS PINNED; HOLD-SL; HOLD-SL; OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.; OUTERSLEEVE F/HOLDING SLEEVE NO. 03.614.
• Patient Sex: Unknown