MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS-STERILE; SCREW,FIXATION,BONE

Model Number	458.952S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Foreign Body In Patient (2687)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event occurred on an unknown date in 2019.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.Reporter is an attorney.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
It was reported that on (b)(6) 2019, the patient underwent revision surgery to remove the defective broken screw.Only one-half of the 5.0 mm locking screw was able to be removed.On or about (b)(6) 2018, the patient fell and fractured his left hip.On or about (b)(6) 2018, the patient underwent hip pinning surgery on his left hip and was implanted with a synthes tfn advanced proximal femoral nailing system device into the left hip and left femur consisting of synthes tfn advanced system long nail 12mm distal diameter, titanium helical blade 100 mm, and one (1) synthes 5.0 mm (5x52 mm) titanium locking screw with hexagonal drive.In (b)(6) 2019, plaintiff began to experience discomfort and pain in the left hip, thigh, and above the knee area.On or about (b)(6) 2019, the patient was advised that the implanted femoral screw was broken.Concomitant device reported: tfn advanced system long nail (part# unknown, lot# unknown, quantity# 1); titanium helical blade (part# unknown, lot# unknown, quantity# 1).This report is for one (1) 5.0mm ti locking screw 52mm- for im nails-sterile.This is report 1 of 1 for (b)(4).
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: d4: updated.Investigation summary :product was not returned.Based on the information available, it has been determined that no corrective and 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 h3, h4, h6: device history lot.Manufacturing location: monument.Manufacturing date: 30-jun-2016.Expiration date: 31-may-2025.Part number: 458.952s, 5.0mm ti locking screw 52mm for im nails ¿ sterile.Lot number: h120122 (sterile).Lot quantity: 120.Work order traveler met all inspection acceptance criteria.Inspection sheet, final inspection, rev h met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf rev j was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 12692 by sterigenics was reviewed and determined to be conforming.This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component(s) reviewed: part number: 459.052.999, 5.0mm ti screw blank 52mm locking bolt w/3.5 hex.Lot number: 9811603.Lot quantity: 494.Work order traveler met all inspection acceptance criteria.Part number: 23020, tialnbci4.98.Lot number: 7381736.Lot quantity: 1,807 lbs.Certified test report supplied by perryman company dated 04-dec-2012 and inspection certificate supplied to perryman by vsmpo dated 10-jul-2012 were reviewed and determined to be conforming.Lot summary report dated 08-may-2013 met all inspection acceptance criteria.Raw material receiving/put away checklist met all inspection acceptance criteria.Device history batch null, device history review 23-mar-2021: this lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H11:g4/updated.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.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: 5.0MM TI LOCKING SCREW 52MM- FOR IM NAILS-STERILE
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11446752
• Report Number: 2939274-2021-01269
• Device Sequence Number: 4040391
• Product Code: HWC
• UDI-Device Identifier: 10886982230980
• UDI-Public: 10886982230980
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K000089
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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 Expiration Date: 05/31/2025
• Device Model Number: 458.952S
• Device Catalogue Number: 458.952S
• Device Lot Number: H120122
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 03/24/2021; 05/10/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 04/02/2021; 06/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR