MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM FOR 4.0MM RODS; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.615.022S

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Additional product codes kwp, mnh, mni.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).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) 2018, the surgeon recognized a movement of two (2) cancellous bone screws as shown under x-ray images.The patient underwent an initial surgery on (b)(6) 2018, to treat an atlantoaxial subluxation at o-c2.A revision surgery is scheduled for an unknown date.This report is for one (1) 3.5mm ti cancellous polyaxial screw 22mm for 4.0mm rods.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Added concomitant devices.Date device returned to manufacturer.The device has been received, the investigation is in progress, 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 Description

Further it was clarified that the surgeon recognized a movement of two (2) cancellous bone screws as shown under x-ray images on (b)(6) 2018 and not on (b)(6) 2018 as reported in initial medwatch.It was also clarified that the additionally reported four (4) locking screws have no allegation against them.Concomitant: locking screw (part# 04.614.508s, lot# h586129, quantity# 4).

Event Description

Additionally, four (4) locking caps were returned to affiliate and were determined to be reported as loose.This is report 1 of 6 for (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.B5 d4: expiration date e1: reporter name h11 corrected data: b4/b4: these dates were incorrectly reported as 9/11/208.The correct date is 9/12/2018.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 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: device history record (dhr) review: part number 04.615.022s; lot number: 7678277(sterile - monument) / 7668826 (non-sterile - brandywine); date of manufacture: may 22, 2014; place of manufacture: brandywine plant; part expiration date: may 2024.Brandywine dhr review: part number: 04.615.022y; lot number: 7668826; date of manufacture: april 21, 2014; place of manufacture: brandywine; part expiration date: none; list of nonconformances: none.Description of dhr review: no nonconformance records (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.The device history record(s) showed that there were no nonconformances or issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: investigation summary: complaint condition: it was reported that there was a movement of the two (2) cancellous bone screw recognized by the surgeon under x-ray on september 12, 2018.The patient underwent an initial surgery on august 31, 2018, to treat an atlantoaxial subluxation at o-c2.A revision surgery is to be performed on an unknown date (see action: a-1430418).Customer quality investigation: investigation flow: damage-visual appearance not as expected: device condition: visual inspection performed at customer quality (cq) observed one of the deformed threads on the returned synapse screw which is consistent with the reported screw migration condition.The first proximal thread of the device appeared worn and deformed in the form of nicks and dents.No new issues were noted on other portions of the device.The x-ray images that provides the evidence of screw movement was not provided.However, with the observed issue on the device shaft the complaint condition was confirmed.Dimensional analysis and document/specification review: relevant drawings for the returned instrument were reviewed (both from the time of manufacture and present revision) were reviewed and no design issues were identified.Dimensional analysis was not performed at the relevant portions due to post manufacture deformed condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.No ncrs were generated during production.Furthermore, the risk document review performed during investigation showed that the windchill dcrm document, completely addresses the given complaint condition (see related action).A definitive root cause could not be determined based on the provided information.However, the failure mode is typically associated with the application of excessive mis-aligned/off-axis force during screw insertion.Conclusion: the overall complaint condition was confirmed; however, no product design issues or manufacturing discrepancies were identified during this investigation.Based on the investigation findings, it has been determined that no corrective and/or preventative 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.

• Brand Name: 3.5MM TI CANCELLOUS POLYAXIAL SCREW 22MM FOR 4.0MM RODS
• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7930822
• MDR Text Key: 122615863
• Report Number: 8030965-2018-56961
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819477001
• UDI-Public: (01)07611819477001
• Combination Product (y/n): N
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.615.022S
• Device Lot Number: 7668826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Date Manufacturer Received: 10/31/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR