MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11 TI CANN RETRO/ANTEGRADE FEM NL/340-S; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.548S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.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 device history lot: manufacturing location: (b)(4), manufacturing date: 23-aug-2021, expiration date: 31-jul-2030, part number: 04.013.548s, 11mm ti cann retro/antegrade femoral nail-ex/340mm , lot number: 338p046 (sterile), lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in process / inspect dimensional / final, ns072594 met all inspection acceptance criteria.Packaging label log (pll) lppf, 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 20531 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(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿surgeon was having difficulties due to the nail not being properly connected¿ does not indicate breakage of the nail therefore, review of the raw materials would not be pertinent to the reported complaint condition.Device history review: 24-sep-2021: 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.
Event or Problem Description
It was reported that on (b)(6) 2021 the patient underwent for a surgery.During the surgery, while inserting a rafn nail, the surgeon was having difficulties drilling the nail.It was determined that the nail was not properly connected.The guide was correctly aligned and reconnect handle.No fragments were generated.There were 10 minutes surgical delay.The procedure successfully completed.No patient consequences.Concomitant device reported: unk - drill: (part# unknown; lot# unknown; quantity: unknown).Unk - nail insertion handles (part# unknown; lot# unknown; quantity: unknown).Unk - guides/sleeves/aiming: guide (part# unknown; lot# unknown; quantity: unknown).This complaint involves one (1) device.This report is for (1) 11 ti cann retro/antegrade fem nl/340-s.This report is 1 of 1 of (b)(4).

• Brand Name: 11 TI CANN RETRO/ANTEGRADE FEM NL/340-S
• 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: 12648315
• Report Number: 2939274-2021-06150
• Device Sequence Number: 1713026
• Product Code: HSB
• UDI-Device Identifier: 10886982088031
• UDI-Public: (01)10886982088031
• 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
• Device Implanted Year: 2021
• 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): 09/20/2021

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 Model Number: 04.013.548S
• Device Catalogue Number: 04.013.548S
• Device Lot Number: 338P046
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 10/18/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - DRILL; UNK - GUIDES/SLEEVES/AIMING: GUIDE; UNK - NAIL INSERTION HANDLES
• Patient Age: 40 YR
• Patient Weight: 49