MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 15MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.013.956S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Sterile: part: 04.013.956s, lot: 7108744, manufacturing site: (b)(4), supplier: (b)(4), release to warehouse date: january 14, 2013, expiry date: january 1, 2023.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: non-sterile: part: 04.013.956, lot: 7108744, manufacturing site: (b)(4).Manufacturing location: (b)(4).Manufacturing date: 11-mar-2011 / released as non-sterile lot number 7108744: 15-dec-2012 part number: 04.013.456, 15mm ti cann retro/antegrade femoral nail-ex/380mm lot number: 6610842 (sterile) repackaged as lot number: 7108744 (non-sterile) lot quantity: 6 (6610842) / 1 (7108744) work order traveler met all inspection acceptance criteria.Inspection sheet, in-process acceptance met all inspection acceptance criteria.Inspection sheet, inspect dimensional met all inspection acceptance criteria.Inspection sheet, final inspection met all inspection acceptance criteria.Packaging label log lppf, lmd/lpf was reviewed and determined to be conforming.Packaging bom was reviewed and all components issued met current defined requirements.Packaging label log lppf, lmd/lpf (non-sterile) was reviewed and determined to be conforming.This lot met all dimensional, visual 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: component parts were not reviewed as the reported complaint condition of ¿surgeon hit nail with drill bit¿ does not indicate breakage of the nail.Therefore, review of the raw material would not be pertinent to the reported complaint condition.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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) 2021, while inserting a titanium cannulated femoral nail, the surgeon hit the nail with the second most distal screw drill bit.Adjustments were made and the surgeon was able to place the screw successfully.The surgeon was leaning on the aiming arm causing it to bend and miss the nail.It is unknown if there was surgical delay reported.Patient status is unknown.This report involves one (1) 15mm ti cann retro/antegrade femoral nail-ex/380mm-sterile.This is report 1 of 5 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

• Brand Name: 15MM TI CANN RETRO/ANTEGRADE FEMORAL NAIL-EX/380MM-STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11692796
• Report Number: 2939274-2021-01943
• Device Sequence Number: 19601266
• Product Code: HSB
• UDI-Device Identifier: 10886982088734
• UDI-Public: (01)10886982088734
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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 Expiration Date: 01/01/2023
• Device Model Number: 04.013.956S
• Device Catalogue Number: 04.013.956S
• Device Lot Number: 7108744
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/20/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM; UNK - NAIL INSERTION HANDLES; UNK - SCREWS: LOCKING
• Patient Age: 34 YR
• Patient Weight: 79