MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	456.511S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	05/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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
Device report from synthes reports an event in (b)(6) as follows: it was reported the surgeon had an issue getting the helical blade through the trochanteric fixation nail (tfn) during a procedure on (b)(6) 2020.The helical blade made contact with the left hand side/proximal part of the hole gliding hole.The tfn and helical blade impacts were removed and a new nail and blade were used with no conflict.There is a possibility the connecting screw that connects to the tfn was loose however, there were no issues with instruments when testing the implants post surgery.There was a 5 minute surgical delay but no patient complications.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.H10 additional narrative: patient code 3191 used to capture surgical delay 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: h3, h6: the device was received, the investigation is in progress, 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.
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: manufacturing location: monument, manufacturing date: december 05, 2019, part: 456.511s, 12mm/130 deg ti cann troch fixation nail 235mm-sterile, expiration date: october 31, 2028, lot: 29p0928 (sterile).Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Sterilization control number (scn) supplied by ethicon (abq) was reviewed and determined to be conforming.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.Component part(s) reviewed: part: 21069, tialnbri18.00, lot: h105625.Certificate of test supplied by ati specialty materials was reviewed and determined to be conforming.Lot summary report met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Visual inspection: the tfn ø12 130° l235 tan green was received at us customer quality (cq).Visual inspection of the complaint device showed some drill marks on the left/proximal side.Additionally, there was a deformation/notch on the left/proximal side as well.Functional test: a full functional assessment was unable to be performed on the complaint device since all the mating devices were not returned.However, the returned helical blade mating device was able to assemble with the complaint device.The complaint was not able to be replicated.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Document/specification review: current and manufactured revisions were reviewed.No design issues or discrepancies were identified.Investigation conclusion: this complaint is not confirmed as a full functional test could not be performed and the devices were able to assemble.Additionally, there are drill marks and a deformation on the left/proximal side of the nail.No definitive root cause could be determined based on the provided information.There was no indication that a design or manufacturing issue contributed to the complaint.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.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: 12MM/130 DEG TI CANN TROCH FIXATION NAIL 235MM-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: 10075598
• Report Number: 2939274-2020-02461
• Device Sequence Number: 14182137
• Product Code: HSB
• UDI-Device Identifier: 10886982228673
• UDI-Public: (01)10886982228673
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/07/2020

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: 456.511S
• Device Catalogue Number: 456.511S
• Device Lot Number: 29PO928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 07/03/2020; 08/06/2020; 08/21/2020
• Initial Report FDA Received Date: 05/20/2020
• Supplement Report FDA Received Date: 07/07/2020; 08/10/2020; 08/24/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HELICAL BLADE F/TFN Ø11 L110 TAN GOLD; HELICAL BLADE F/TFN Ø11 L110 TAN GOLD; UNK - INSERTION INSTRUMENTS: CONNECTING SCREW; UNK - INSERTION INSTRUMENTS: CONNECTING SCREW; HELICAL BLADE F/TFN Ø11 L110 TAN GOLD; UNK - INSERTION INSTRUMENTS: CONNECTING SCREW