MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH TI LOCKING SCREW; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number 04.614.508S

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event is unknown.(b)(4).The device was received and the product evaluation is in progress.No conclusion can be drawn.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 europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2018, patient underwent revision surgery because two screws were dislocated.During the re-operation at o-c2, it was noted that the head of the cancellous bone screw synapse and set screw came off.As a result, the surgeon extracted two rods and two screws at c2, and inserted new screws at c2 and c3 as well to tighten the rods again.The re-operation was completed successfully, and there was no adverse consequence to the patient.There were no issues during the revision surgery.Patient was reported as stable.Concomitant devices reported: rod: ( part# unknown, lot# unknown, quantity unknown); lockscr synapse tan (part# 04.614.508s, lot# h510836, quantity 1); lockscr synapse tan (part# 04.614.508s, lot# h484545, quantity 1); lockscr synapse tan (part# 04.614.508s, lot# h510835, quantity 1).This report is for one (1) ti locking screw.This is report 2 of 2 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.D4: possible lot#s are: h510836, h484545 or h510835 h3, h4, h6: device history records review was completed for part# 04.615.508, lot# h510835.Manufacturing location: monument, manufacturing date: jan 05, 2018.Product inspected and passed.Certificate of compliance, received from general machine, inc, certifies product was manufactured to the requirements and customer and/or industry requirements.No non-conformances or reworks were generated during the manufacture of this lot.Component lot bk100018/h386690.Device history records review was completed for part# 04.615.508, lot# h510836.Manufacturing location: monument, manufacturing date: jan 05, 2018.Product inspected and passed.Certificate of compliance, received from general machine, inc, certifies product was manufactured to the requirements and customer and/or industry requirements.No non-conformances or reworks were generated during the manufacture of this lot.Component lot bk100018/h386690.Device history records review was completed for part# 04.615.508, lot# h484545.Manufacturing location: monument, manufacturing date: dec 12, 2017.Product inspected and passed.Certificate of compliance, received from general machine, inc, certifies product was manufactured to the requirements and customer and/or industry requirements.No non-conformances or reworks were generated during the manufacture of this lot.Component lot bk100018/h386687.Device history records review was completed for part# bk100018, lot# h386690.Manufacturing location: monument, manufacturing date: nov 09, 2017.Product inspected and passed.Certificate of compliance, received from universal punch corp, certifies product was manufactured to the requirements and customer and/or industry requirements.No non-conformances or reworks were generated during the manufacture of this lot.Raw material lot 21039/7439768.Device history records review was completed for part# bk100018, lot# h386687.Manufacturing location: monument, manufacturing date: jan 05, 2018.Product inspected and passed.Certificate of compliance, received from universal punch corp, certifies product was manufactured to the requirements and customer and/or industry requirements.No non-conformances or reworks were generated during the manufacture of this lot.Raw material lot 21039/7439768.Raw material 21039 - 7439768 originally received on 23 mar 2017 from brandywine into monument; brandywine received from perryman company 26 jul 2013.Certified test report and certificate of test also received from perryman company.Lot summary report and putaway checklist indicate that material passed requirements.There were no non-conformances or reworks generated during the manufacture of this material.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the products that would contribute to this complaint condition.H3, h6: product development investigation was completed.Four locking/set screws (04.614.508) lots: h510835 (quantity 1), h510836 (quantity 2), and h484545 (quantity 1) were returned and investigated by cq.It was not clarified which screw experienced the complaint condition.No major damage was noted to any feature of the four screws.All four showed very minor wear consistent with implantation and interaction with the rod.Minor deformation was noticed to the drive recess for two screws, lot h510836.None of the noted minor damage would impact function of the devices.Functional testing could not be performed, as the rod was not returned.All four screws were able to assemble properly to the returned cancellous screw body (04.615.008.2/lot h364792), no toggling or looseness was observed.The received condition does not agree with the complaint condition.The complaint could not be replicated with the returned devices.The major thread diameter of all four locking screws was within specification of 7.35mm +/-0.05 per drawing.Lots h510835 (quantity 1), h510836 (quantity 2) measured 7.37mm.Lot h484545 (quantity 1) measured 7.36mm.The height/thickness (ventral-dorsal) of the screws measured within specification of 3.25mm +/- 0.05 per drawing.Lot h510836 (quantity 2) measured 3.25mm.Lot h484545 (quantity 1) measured 3.27mm.Lot h510835 (quantity 1) measured 3.28mm.All measurements were taken using ca215.A relevant drawing was reviewed during investigation.During the investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.The complaint condition was not confirmed during investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.No issues were observed with the features of the returned cancellous screw body (04.615.008.2/lot h364792) that interact with the set screw.It is possible that the assembled device experienced extreme forces while implanted, which would contribute to the complaint condition.It has been determined that no corrective and/or preventive action is proposed.H11 corrected data: b5, d11: updated concomitant devices.Possible lot#s for part 04.614.508s are either h510836, h484545 or h510835.Exact lot # is unknown.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

Concomitant devices reported: rod: ( part# unknown, lot# unknown, quantity unknown).Lockscr synapse tan (part# 04.614.508s, lot# unknown, quantity 2).

• Brand Name: TI LOCKING SCREW
• 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: 7639229
• MDR Text Key: 112417496
• Report Number: 8030965-2018-54650
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07611819328747
• UDI-Public: (01)07611819328747
• 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
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Date Manufacturer Received: 08/30/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR