MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED HELICAL BLADE 75 - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.375S
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional procode: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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 history lot: part # 04.038.375s, synthes lot # h566892, supplier lot # n/a, release to warehouse date: 12 apr 2018, expiration date: 31 mar 2028, manufacturing location: (b)(4), no ncr's were generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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, during an unknown procedure, while inserting a tfna nail, the surgeon perforated the femoral neck with the helical blade.The nail and helical blade were extracted, and reinserted.The helical blade was repositioned in the femoral neck and the surgery was completed successfully.During extraction, one of the prongs of the connection interface was slightly bent; however the nail was successfully reconnected and inserted.There was a fifteen (15) minute surgical delay.The procedure was successfully completed with no patient consequences.This report is for one (1) tfna fenestrated helical blade 75 - sile.This is report 1 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED HELICAL BLADE 75 - SILE
• 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: 12639890
• Report Number: 2939274-2021-06125
• Device Sequence Number: 3413479
• Product Code: HSB
• UDI-Device Identifier: 10886982099198
• UDI-Public: 10886982099198
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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): 09/17/2021

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 Model Number: 04.038.375S
• Device Catalogue Number: 04.038.375S
• Device Lot Number: H566892
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/15/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10/130 DEG TI CANN TFNA 340/LEFT - SILE; RIA 2 BONE HARVESTING KIT 520MM STERILE
• Patient Age: 48 YR
• Patient Weight: 68