MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX TOP LOADING POLYAXIAL HEAD; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 04.632.001

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: date of event is an unknown date in 2021.Procode: additional procodes: kwp, kwq, mnh, mni.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) reports an event as follows: it was reported that during an a & p lumbar fusion on an unknown date, the surgeon used a polyaxial head positioner to place the polyaxial head implant onto the bone screw.An audible breaking sound was heard by surgeon and assistant.The head positioner instrument was removed, and the polyaxial head implant was not fixed to bone screw; it was loose and fished out with a forcep.The surgical assistant then noticed a piece of small metal left behind, which was taken out via a forcep.A new sterile polyaxial head implant was opened and used for the case to be completed.On further inspection of the first implant, the collet inside of the polyaxial head had broken.All pieces were removed, decontaminated, and cleaned for pick up.Procedure was completed successfully with no delay.There was no patient consequence.This report is for a titanium (ti) matrix top loading polyaxial head.This is report 1 of 1 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.H10 additional narrative: d9.H3, h6: a product investigation was conducted.Visual inspection: ti matrix top loading polyaxial head (part # 04.632.001, lot # 91p6057) was received as an assembly at us cq.Upon visual inspection at cq, it is observed that subcomponent collet (04_632_420_3) was broken.No other issues were observed with the returned device.Dimensional inspection: no dimensional inspection can be performed due to post-manufacturing damage.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the design of the device.Document/ specification review: the relevant drawings were reviewed during investigation: no design issues were found which can contribute to this complaint condition.Investigation conclusion: this complaint is confirmed to be broken.Although no definitive root-cause can be determined it is likely the device encountered unintended forces during use.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive 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 number: 04.632.001.Lot number: 91p6057.Part manufacture date: 02-09-2021.Manufacturing location: brandywine.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record of this lot revealed no complaint-related anomalies.The device history record shows that the ti matrix top loading polyaxial head was processed through the normal manufacturing, finishing, assembly, packaging, and inspection operations.The product lot met all acceptance criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.The product met all manufacturing, finishing, assembly, packaging, and inspection acceptance criteria at the time of release with no issues documented during manufacture 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.D4; g1; h4.

• Brand Name: TI MATRIX TOP LOADING POLYAXIAL HEAD
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12188827
• MDR Text Key: 262258733
• Report Number: 8030965-2021-05875
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819364929
• UDI-Public: (01)07611819364929
• Combination Product (y/n): N
• PMA/PMN Number: K100952
• 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: 06/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.001
• Device Lot Number: 91P6057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2021
• Date Manufacturer Received: 07/20/2021
• Patient Sequence Number: 1
• Treatment: UNKNOWN POLYAXIAL HEAD POSITIONER; UNKNOWN SCREW MATRIX; UNKNOWN POLYAXIAL HEAD POSITIONER; UNKNOWN SCREW MATRIX