MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11.0MM TI HELICAL BLADE 105MM-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.306S
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for im nailing of proximal femur fix.During the procedure, locking mechanism does not fully seated.Prong most likely did not have enough space to pass into between groove in blade and inside wall of tfna nail.The procedure completed successfully.There was no patient consequence.Concomitant device reported: 5.0mm ti locking screw w/t25 stardrive 34mm f/im nail-ster.(part# 04.005.524s; lot# 54p3760; quantity: 1).This complaint involves two (2) devices.This report is for (1) 11.0mm ti helical blade 105mm-sterile.This is report 2 of 2 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.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.The device was not returned.A photo-investigation was performed on the images.No device issues were noted.It was apparent in the images that tfn helical blade was used; the implanted nail had similar features to the tfna nail family.The insertion handle appeared to be connected to the nail, and the locking mechanism appear to be in the unlocked position.No device issues were noted.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion: the complaint condition was confirmed during photo investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.The assembly issue was attributed to the use of two incompatible devices used together by the user.No device issues were observed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot manufacturing location: elmira / packaged, sterilized and released by: monument, manufacturing date: 08-oct-2019, expiration date: 31-aug-2028, part number: 456.306s, 11mm ti helical blade 105mm -sterile, lot number: 18p2311 (sterile), lot quantity: 24.Note: helical blade was manufactured by elmira; lot number 17p4293.Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll), lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn supplied by sterigenics was reviewed and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Device history review nov 05, 2020: dhr reviewed.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: 11.0MM TI HELICAL BLADE 105MM-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10787497
• Report Number: 2939274-2020-04976
• Device Sequence Number: 14193004
• Product Code: HSB
• UDI-Device Identifier: 10886982226747
• UDI-Public: (01)10886982226747
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2020

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: 456.306S
• Device Catalogue Number: 456.306S
• Device Lot Number: 18P2311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 10/27/2020; 11/24/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/24/2020; 12/09/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10MM/130 DEG TI CANN TFNA 170MM - STERILE; 5.0MM TI LCKNG SCRW W/T25 STDRV 34MM F/IM NAL STR; 10MM/130 DEG TI CANN TFNA 170MM - STERILE; 5.0MM TI LCKNG SCRW W/T25 STDRV 34MM F/IM NAL STR