MAUDE Adverse Event Report: SYNTHES GMBH TI MATRIX TOP LOADING POLYAXIAL HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 04.632.001

Device Problem Compatibility Problem (2960)

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

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Additional device product codes: mnh, kwp, kwq, and mni.Part # 04.632.001 synthes lot # h664622 supplier lot # n/a release to warehouse date: december 6, 2018 manufacturing location: (b)(4) no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Visual inspection: the screw head polyax f/matrix 5.5 tan (p/n: 04.632.001 & lot #: h664622) was returned and received at us customer quality (cq).Upon visual inspection, it was observed that the screw head got stuck.As during the surgery, the surgeon/user replaced the preassembled screw head with this device/screw head but it did not fit well.The screw head didn't sit appropriately on the screw as the screw did not snapped till recess of screw head.Apart from it, minor scratches were visible on the surface of the screw.These might have caused during explantation/removal procedure.No other issues were identified with the returned device.Functional test: the functionality test cannot be performed as the screw is stuck inside the replacement head and the other appropriate instruments that are used to perform the assembly according to surgical guide were not returned.Hence, the functionality test cannot be performed.Can the complaint be replicated with the returned device? unable to perform dimensional inspection: a dimensional inspection cannot be performed due to complex geometry of the screw head.Document/specification review based on the date of manufacture the following drawings, reflecting the current and manufactured revision were reviewed: - surgical technique complaint confirmed? yes, as the pedicle screw is stuck in the screw head.Hence confirming the allegation of unable to disassemble the device.Investigation conclusion the complaint condition was confirmed for the screw head polyax f/matrix 5.5 tan.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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.

Event Description

Device report from synthes reports an event in the (b)(6) as follows: it was reported that on (b)(6) 2020 that the 3-d heads pulled off the pre-assembled screws while the rods were being locked down.Replacement heads were used but this issue occurred again.The damaged screws were removed and longer and wider diameter screws were used to successfully replace the broken screws.The surgery was delayed.This report is for one (1) ti matrix top loading polyaxial head.This is report 5 of 5 for (b)(4).

• Brand Name: TI MATRIX TOP LOADING POLYAXIAL HEAD
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12408531
• MDR Text Key: 280596220
• Report Number: 8030965-2021-07401
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819348226
• UDI-Public: (01)07611819348226
• 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,health professional
• Type of Report: Initial
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• 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: H664622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1
• Treatment: PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM; PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM; PEDICSCR MATRIX 5.5 POLYAXIAL Ø6 PREASSM; SCREW HEAD POLYAX F/MATRIX 5.5 TAN; UNK - RODS