MAUDE Adverse Event Report: SYNTHES GMBH ZERO-P VA IMP 7MM HT LORDOTIC-ST; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Catalog Number	04.647.127S
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2024
Type of Reportable Event	Malfunction
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: d1, d2, d3, d4, g4-510k: this report is for an unknown cage/plate: zero-p va/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.D9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3, h4, h6: 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 or Problem Description
Device report from synthes reports an event in germany as follows: it was reported that on january 18, 2024, the zero p va cage came off of the handle when it was hit two times.After opening another cage, the insertion went without any complications.There were no fragments generated.The procedure was completed successfully.This report involves an unknown cage/plate: zero-p va.This is report 1 of 1 for (b)(4).
Event or Problem Description
No surgical delay was reported.
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.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.
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.H6: photo investigation: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis of the photo revealed that the image quality is poor and no observations pertaining to the nature of the reported event could be identified for zero-p va cage/plate.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for zero-p va cage/plate.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.H3, h6: a product investigation was conducted.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 zero-p va imp 7mm ht lordotic-st was observed with organic material and some deeply scratches at the surface of the device likely caused during the attempt of implantation while the implant was hold with the mating insertion device.Broken condition was not observed.No other issues were identified.Per the zero-p va surgical technique rev.Ab section implant insertion use the insertion device or implant holder to introduce the implant into the disc space.Using the insertion device attach the insertion device to the implant by aligning the recessed grooves located midline on the anterior face of the implant with the pronged tabs of the device tip.Squeeze the insertion device handles to secure the implant; the thumb nut on the insertion device may then be advanced clockwise to affix the implant to the insertion device.Carefully insert the implant into the distracted segment.Advance the implant until the implant stops rest on the anterior surface of the vertebral body.The implant should fit tightly between the endplates.A dimensional inspection for the zero-p va imp 7mm ht lordotic-st was not performed due to post manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the zero-p va imp 7mm ht lordotic-st would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.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.H3, h6: device history record (dhr) review conducted: part number: 04.647.127s, lot number: 535p279, manufacturing site: mezzovico, release to warehouse date: 28 dec 2021, expiration date: 01 nov 2031.A manufacturing record evaluation was performed for the 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: ZERO-P VA IMP 7MM HT LORDOTIC-ST
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico CO 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18586869
• Report Number: 8030965-2024-01397
• Device Sequence Number: 15223014
• Product Code: OVE
• UDI-Device Identifier: 10705034750736
• UDI-Public: (01)10705034750736
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.647.127S
• Device Lot Number: 535P279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 02/16/2024; 04/01/2024
• Initial Report FDA Received Date: 01/26/2024
• Supplement Report FDA Received Date: 03/04/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Unknown