MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM TI CORTEX SCREW SELF-TAPPING 22MM; PLATE,FIXATION,BONE

Model Number	404.822
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(6).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.Occupation: reporter is a j&j representative.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 or Problem Description
It was reported that parts were implanted in 2017.Last year the screws started backing out, and the plate and screws were removed in (b)(6) of 2020.A new plate.Was not implanted at that time due to hospital restrictions on surgeries due to covid.A new plate was implanted in (b)(6) 2021.Patient status is unknown.No surgical delay.This complaint involves (6) devices.This report is for (1) 3.5mm ti cortex screw self-tapping 22mm.This report is 4 of 6 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.Visual inspection: the 3.5mm ti cortex screw self-tapping 22mm (part# 404.822, lot# unk qty# 1) was returned and received at us customer quality (cq).Upon visual inspection, it is observed that the features of the screw shows nicks & scratches consistent with the device use which would not contribute to the complaint condition.Functional test: a complete functional test could not be performed as the properties/state of the patient bone is unknown and its interaction with the devices cannot be tested for.A partial functional test was performed which determined the returned screws interacted with the plate as required.Can the complaint be replicated with the returned device(s)? unable to perform dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to the design of the device.Document/specification review: the following drawing(s) was reviewed: - d3.5mm ti cortex screw self-tapping: current no design issues or discrepancies were found during this investigation.Complaint confirmed? no investigation conclusion: the complaint cannot be confirmed for the 3.5mm ti cortex screw self-tapping 22mm as no x-ray images of the screws backing out from the plate were provided.A definitive root cause could not be identified for the reported problem with the provided information.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 upon these results, 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 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
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.H10 additional narrative: a1: patent identifier: (b)(6).H3, h6: investigation summary: investigation flow: device interaction/functional.Visual inspection: the 3.5mm ti cortex screw self-tapping 22mm (part# 404.822, lot# unk qty# 1) was returned and received at us cq.Upon visual inspection, it is observed that the features of the screw shows nicks & scratches consistent with the device use which would not contribute to the complaint condition.The x-ray images were reviewed.The cortex screw appears to have backed out from its original position.Functional test: a complete functional test could not be performed as the properties/state of the patient bone is unknown and its interaction with the devices cannot be tested for.A partial functional test was performed which determined the returned screws interacted with the plate as required.The complaint can not be replicated with the returned device(s).Dimensional inspection: dimensional inspection of the relevant feature of the received device was not performed at cq due to the design of the device.Document/specification review: no design issues or discrepancies were found during this investigation.Complaint was not confirmed.Investigation conclusion: the complaint is confirmed for the 3.5mm ti cortex screw self-tapping 22mm (part# 404.822, lot# unk qty# 1) as the provided x-ray images show that the screw backed out from its original position.A definitive root cause could not be identified for the reported problem with the provided information.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 upon these results, 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 review a dhr review could not be performed as the device lot number is unknown.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: 3.5MM TI CORTEX SCREW SELF-TAPPING 22MM
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12277533
• Report Number: 2939274-2021-04485
• Device Sequence Number: 14413407
• Product Code: HRS
• UDI-Device Identifier: 10886982207333
• UDI-Public: (01)10886982207333
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131186
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/18/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 404.822
• Device Catalogue Number: 404.822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 08/18/2021; 11/05/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 08/31/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 4.0 TI CANNULATED SCREW SHORT THREAD/46; CORTSCR ø3.5 SELF-TAP L20 TI; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L24 TA; VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L36 TA; VA-LCP OLECR PL 2.7/3.5 LE 2HO L90 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female