MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 7.0MM TI MATRIX POLYAXIAL SCREW 40MM THREAD LENGTH; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	04.632.740
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is unknown in 2020.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.(b)(4).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
It was reported that on unknown date during an unknown procedure, the matrix polyaxial screw detached from an unknown matrix polyaxial head during insertion.The surgeon was using a matrix pre assembled screws in which the shaft and the head of the screw were attached.The surgeon attempted to attach another polyaxial head and it would not attach.The surgeon also noticed that their may have been an issue with the screw shaft head.The matrix polyaxial screw was explanted and a new screw was used.There was surgical delay of three (3) minutes.The procedure was completed successfully.There was no patient consequence reported.This complaint involves three (3) devices.This is report 1 of 3 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Corrected physical manufacturer.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
Concomitant devices reported: ti matrix top loading polyaxial head (part # 04.632.001, lot # unknown, quantity 1); mono/polyaxial head (part # unknown, lot # unknown, quantity 1).
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.H3, h6: a product investigation was conducted.Visual inspection: the product was returned in two pieces - the body (04.632.420.2) and collet (04.632.420.3) were assembled together, and the ø7.0mm matrix screw (04.632.740.1) was separated from the assembly.Damage to the spherical head of the screw - deformation to the leading edge of the spherical radius.Damage to the spherical head of the screw - deformation to the m6.5x0.75-6h internal thread.Functional test: functional inspection unable to be performed due to the device being broken/separated.The complaint can be replicated with the returned device(s).Dimensional inspection: dimensional inspection of the screw spherical radius (dimension sd1 per relevant inspection sheet) was performed.Document/specification review: relevant drawing(s) reviewed: (current & manufactured revisions).No nonconformances or documentation changes related to the complaint condition.Conclusion: the complaint condition of "fell apart - unattached" was confirmed, as it matches the reported condition, but upon further analysis it was determined not to be related to the manufacturing process for the following reasons: 1.The feature of the screw (spherical diameter) that mates with the collet of the assembly was found to be within the product dimensional specification.A visual inspection of the screw also found that the screw head bead blast was present.2.There were also no nonconformances during the production of the compliant products.3.The assembled product and it's components passed all inspection criteria and was found to be within specifications at the time it was released to the warehouse.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, h4, h6: a device history record (dhr) review was conducted: part number: 04.632.740-us, lot number: 34p3434, date of manufacture: 01/14/2020, place of manufacture: brandywine , part expiration date: n/a (nonsterile), list of nonconformances: none.Description of dhr review: no ncrs were generated during production.Dhr is missing a signature and date at step 120 dhr review and release to inventory.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint action.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
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9924250
• Report Number: 2939274-2020-01718
• Device Sequence Number: 3355787
• Product Code: NKB
• UDI-Device Identifier: 10705034745664
• UDI-Public: (01)10705034745664
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/09/2020

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 Model Number: 04.632.740
• Device Catalogue Number: 04.632.740
• Device Lot Number: 34P3434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 04/30/2020; 06/11/2020; 07/24/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 04/30/2020; 06/12/2020; 07/27/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 7.0MM TI MTRX PLYXL SCW 40MM THRD LNTH; TI MATRIX TOP LOADING POLYAXIAL HEAD; UNK - MNO/PLXAL SCW CLRS/SLVS/HDS: MTRX; UNK - MNO/PLXAL SCW CLRS/SLVS/HDS: MTRX
• Patient Age: 47 MO