MAUDE Adverse Event Report: SYNTHES GMBH 9.0MM TI MATRIX POLYAXIAL SCREW 70MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Catalog Number 04.632.970S

Device Problem Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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 on an unknown date that the patient went to see the surgeon for some growing pain, and it was found the screw had broken-off.The patient is scheduled to undergo a revision procedure on (b)(6) 2021.No further information is available.The patient had a posterior thoracolumbar fusion surgery at (b)(6) on (b)(6) 2020.Concomitant device reported: unk - plate: (part# unknown; lot# unknown; quantity: 1).This complaint involves one (1) device.This report is for (1) 9.0mm ti matrix polyaxial screw 80mm thread length.This is report 1 of 1 (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.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.

Manufacturer Narrative

Product complaint # (b)(4).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.H3, h6: investigation summary : the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual review of the returned device revealed that the screw implant was broken approximately at the neck just below the head.The broken piece was also received at us cq.The most proximal thread in the screw shank was stripped.The dimensional inspection was not performed due to the post-manufacturing damage.The cause for the breakage could not be identified.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of synthes 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.No definitive root cause can be determined.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.Document/specification review; the relevant drawing is reflecting the current and manufactured revision was reviewed.Device history lot.Part number:04.632.970s, synthes lot number: h449268, supplier lot number: n/a, release to warehouse date: sep 12, 2017, expiration date: sep 12, 2037, manufactured by synthes brandywine.No ncrs were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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: 9.0MM TI MATRIX POLYAXIAL SCREW 70MM THREAD LENGTH
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11275736
• MDR Text Key: 230461671
• Report Number: 8030965-2021-00819
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07611819366046
• UDI-Public: 7611819366046
• 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,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.632.970S
• Device Lot Number: H449268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Date Manufacturer Received: 03/11/2021
• Patient Sequence Number: 1
• Treatment: UNK - PLATES
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR