MAUDE Adverse Event Report: SYNTHES GMBH 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 04.632.740S

Device Problem Material Integrity Problem (2978)

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

Event Date 01/12/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter facility name: (b)(4) medical center.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, during a plif at l5-s for treatment of spinal canal stenosis the screw split into the screwhead and shaft when the surgeon had to extract an inserted screw.The surgeon was able to remove the two fragments of the screw and the sleeve.It was confirmed that no fragments were left in the patient¿s body.There was a less than thirty (30) minute surgical delay.The procedure was completed and the patient was reported as stable.Concomitant devices reported: retain-sleeve std f/matrix 5.5 (part number 03.632.001, lot 6705459, quantity 1).This report involves one (1) 7.0mm ti matrix polyaxial screw 40mm thread length.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h4, h6: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the received device.Visual analysis of the returned sample revealed that the screw shank component got separated from the head component.A small portion of the proximal threaded head in the shank component was broken off.The dimensional analysis was not performed due to the post-manufacturing damage.The fell apart and broken condition of the received screw implant was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.It should be noted that as part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as visual inspection of the received device confirmed the broken condition.While no definitive root cause could be determined, it is possible that the alleged broken and fell apart condition may be occurred due to a random component failure that may have been caused by exposure to unintended/overt forces.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities device history lot: this mre review is for sterilization procedure only part: 04.632.740s.Lot: 6l58315.Manufacturing site: selzach.Supplier: (b)(4).Release to warehouse date: 14.Jan 2020.Expiry date: 01.Jan 2030.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile 04.632.740 / h641918 was manufactured in us, brandywine.Completed by: (b)(6).Part number: 04.632.740.Lot number: h641918.Part manufacture date: 05-25-2018.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 7.0mm matrix assembly was processed through the normal machining, inspection, and finishing operations.The product lot had met all machining, inspection, and finishing acceptance criteria at the time of release with no issues documented during manufacture that would contribute to this complaint condition.The product met all machining, inspection, and finishing 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.

• Brand Name: 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11260020
• MDR Text Key: 230627594
• Report Number: 8030965-2021-00755
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819365698
• UDI-Public: (01)07611819365698
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.740S
• Device Lot Number: H641918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/19/2021
• Patient Sequence Number: 1
• Treatment: RETAIN-SLEEVE STD F/MATRIX 5.5