MAUDE Adverse Event Report: SYNTHES GMBH 6.0MM TI MATRIX SCREW 35MM THREAD LENGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 04.639.635

Device Problem Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Additional device product codes: mni, mnh, nkb, kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.This report was initially reported on march 9, 2021 under manufacturer report number 1526439-2021-00418 for depuy spine.On april 14, 2021, it was determined the device actually was the reporting responsibility of synthes spine.The report is now being submitted under the correct manufacturer.(b)(4).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 Description

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient initially underwent the surgery on (b)(6) 2020 for l4-l5-s1 arthrodesis.Since then patient had suffered a breakage of screws and vertebral matrix fixator, with problems and sequelae caused after l4-l5-s1 arthrodesis, with torsion breakage and suspension bars and imprint, with need of surgical re-intervention, removal of fixator and rearridesis 360.No further information provided.This report is for one (1) 6.0mm ti matrix screw 35mm thread length.This is report 2 of 4 for complaint (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.H6: part: 04.639.635, lot: 9865148, supplier lot: n/a, manufacture date or release to warehouse date: july 29, 2015, expiration date: n/a, supplier/manufacture site: (b)(4).No nonconformance reports (ncrs) were generated during production lot 9865148.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.Review of the device history record(s) showed that there were no issues during the manufacture of the non-sterile product that would contribute to this complaint condition.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: 6.0MM TI MATRIX SCREW 35MM THREAD LENGTH
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11702050
• MDR Text Key: 246561984
• Report Number: 8030965-2021-03127
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 10705034749297
• UDI-Public: (01)10705034749297
• Combination Product (y/n): N
• PMA/PMN Number: K100952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.639.635
• Device Catalogue Number: 04.639.635
• Device Lot Number: 9865148
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Patient Sequence Number: 1
• Treatment: 5.5MM TI CURVED ROD 70MM; 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH; 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH; MATRIX LOCKING CAP WITHOUT SADDLE; 5.5MM TI CURVED ROD 70MM; 6.0MM TI MATRIX SCREW 45MM THREAD LENGTH; 6.0MM TI MATRIX SCREW 50MM THREAD LENGTH; MATRIX LOCKING CAP WITHOUT SADDLE
• Patient Outcome(s): Required Intervention