MAUDE Adverse Event Report: SYNTHES GMBH TI LOCKING SCREW; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number 04.614.508

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown occipital screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 an occipital screw became loose.The loosening was noticed on the x-ray post-surgery and the patient complained about pain and slow wound healing.Revision surgery was planned for (b)(6) 2021.This report is for an unknown occipital screw.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.The device was not returned.A photo-investigation was performed on the images provided.Upon inspecting all the images provided under notes & attachments section, it is observed that the unk - screws: occipital have been migrated from the position, hence confirming the allegation as the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion : the complaint condition can be confirmed during photo/video investigation.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.Visual inspection: the ti locking screw (p/n: 04.614.508, lot number: 32p5696) was received at us cq.Upon inspecting the device, minor nicks and scratches were observed on the device, which could have caused during the implantation and explantation process.No other issues were identified.The provided photographs in the pc attachments were reviewed and it was observed that the device migrated from its implanted location.Functional test: a functional assessment could not be performed.However the provided photographs in the pc attachments confirms the complaint condition.Device failure/defect identified? yes.Document/specification review: no design issues or discrepancies were noticed.Complaint confirmed? yes.Investigation conclusion: this complaint is confirmed as the device migrated from its implanted position.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 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 manufacturing location: supplier ¿ eptam precision metals / inspected, packaged and released by: monument.Release to warehouse date: 06-jan-2020, part number: 04.614.508, ti locking screw, lot number: 32p5696 (non-sterile).One piece was scrapped in cell at op #10, vendor machine, for tool marks in the surface finish.Production order traveler met all inspection acceptance criteria apart from the one piece noted.Inspection sheet, incoming final inspection, ns073160 rev a met all inspection acceptance criteria.Certificate of conformance supplied by eptam dated 23-dec-2019 was reviewed and determined to be conforming.Packaging label log (pll) lmd rev ac was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of this product that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿screw loosened¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported 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.D2: additional procode: kwp, mnh, nkg.

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.Photo investigation: the device was not returned.A photo-investigation was performed on the images.Upon inspecting all the images provided under notes & attachments section, it is observed that the unk - screws: occipital have been migrated from the position, hence confirming the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition can be confirmed during photo/video investigation.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 history review: the device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed.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: TI LOCKING SCREW
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12488045
• MDR Text Key: 271900830
• Report Number: 8030965-2021-07831
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Device Lot Number: 32P5696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - CRANIAL CLAMPS/CLIPS; UNK - PLATES: TRAUMA; UNK - RODS; UNK - CRANIAL CLAMPS/CLIPS; UNK - PLATES: TRAUMA; UNK - RODS
• Patient Outcome(s): Required Intervention
• Patient Sex: Female