MAUDE Adverse Event Report: SYNTHES GMBH 4.5MM TI OCCIPITAL SCREW 10MM; ORTHOSIS, SPINAL PEDICLE FIXATION

Catalog Number	04.601.110
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/27/2023
Type of Reportable Event	Serious Injury
Additional 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: d2: additional procodes: nkg, kwp, mnh d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.D10: date of concomitant therapy is (b)(6) 2023.E3: initial reporter is a synthes employee.G4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h6: 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 or Problem Description
Device report from japan reports an event as follows: it was reported that the patient underwent a posterior cervical fusion (o-c4) on (b)(6) 2023 that was completed successfully with no surgical delay.On (b)(6) 2023 the patient came to the outpatient clinic, where it was discovered that the two screws in question had loosened from the occipital bone.Revision surgery was scheduled for (b)(6) 2023 to replace the occipital bone plate and the bone screws in question.The cause of the loosening is unknown.No further information is available.This report is for a 4.5mm ti occipital screw 10mm.This is report 1 of 4 for (b)(4).
Additional 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.H3,h4, h6 the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that 4.5mm ti occipital screw 10mm appears to be in good condition.No signs of defects were observed on the threaded shaft nor the drive portion of the screw.No issues nor malfunction that could have contributed to the reported event were observed.A dimensional inspection was performed for the 4.5mm ti occipital screw 10mm and met specifications.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not as the observed condition of the 4.5mm ti occipital screw 10mm would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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.Drawing/specifications reviewed 04_601_140 rev.C current and manufactured dimensional inspection: specified dimensions: length: ø shaft: measured dimensions: length: mm (complies) ø shaft: (complies) device used ¿ digimatic caliper (b)(4).H4, h6 04.601.110s lot # 8l61668 manufacturing site: werk selzach logistik release to warehouse date: 24.Sep.2021 expiration date: 01.Sep.2031 supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part #: 04.601.110 non-sterile lot #: 316p681 manufacturing site: mezzovico release to warehouse date: 09 aug 2021.A manufacturing record evaluation was performed for the not sterile finished lot number, and no non-conformances were identified.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: 4.5MM TI OCCIPITAL SCREW 10MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MEZZOVICO; via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18346006
• Report Number: 8030965-2023-15834
• Device Sequence Number: 6222453
• Product Code: MNI
• UDI-Device Identifier: 10705034734309
• UDI-Public: (01)10705034734309
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 04.601.110
• Device Lot Number: 316P681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: OCCIPIT-SCR ø4.5 L14 TAN; OCCIPIT-SCR ø5 L12 TAN; OCCIPITAL-PL 4.5/5 MED W/50 F/R ø4 TI
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown