MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.031S

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.(b)(4).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 Description

It was reported that on (b)(6) 2020, during a hip surgery while doing proximal femoral nailing system (tfna) on a midshaft femur fracture, the fracture was reduced, reamed and implanted using a tfna nail.After getting the tfna nail down the canal, the triple sleeve was used to insert the unknown lag screw.The surgeon proceeded with the steps and inserted the unknown lag screw.The surgeon was unsuccessful in locking the set screw.It was found that the nail disconnected from the unknown aiming arm and the unknown lag screw missed the hole in the nail.The surgeon proceeded to extract the nail and was successful in removing it with the extraction hook.The surgeon opened a new nail and properly assembled it onto the aiming arm before implanting the new nail and unknown lag screw and proceeding with the rest of the case.There was a one hundred twenty (120) minute surgical delay.The procedure was successfully completed.The patient outcome is unknown.This complaint involves six (6) devices.This report is for (1) 10mm/125 deg ti cann tfna 400mm/left ¿ sterile.This is report 1 of 6 for (b)(4).

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: b5, d11: updated concomitant devices.H6: a product investigation was conducted.Visual inspection: it was further noted that there were scratches and a drill mark on the outside body of the device which have no impact on the device functionality.Investigation conclusion: the complaint condition was confirmed for the 10mm/125 deg ti cann tfna 400mm/left - sterile (p/n: 04.037.031s & lot #: h225115).The potential root cause for the nicked drill mark could be due to the miss alignment of the drill during the drilling procedure.The scratches on the insertion handle interface could be due to the devices that were used while extracting the nail.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.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 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.

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.

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, h4, h6: the 10mm/125 deg ti cann tfna 400mm/left - sterile (p/n: 04.037.031s & lot #: h225115) was returned and received at us cq.Upon visual inspection, it was observed that the tang cut section of the nail was broken which could have contributed to the complaint condition.There were scratches on the device which have no impact on the device functionality.No other issues were identified with the returned device.The complaint condition was confirmed for the 10mm/125 deg ti cann tfna 400mm/left - sterile (p/n: 04.037.031s & lot #: h225115).There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues, or discrepancies were observed that may have contributed to the complaint condition.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: monument.Manufacturing date: 04-nov-2016.Expiration date: 30-nov-2026.Part number: 04.037.031s, 10mm/125 deg ti cann tfna 400mm/left ¿ sterile.Lot number: h225115 (sterile).Component parts reviewed: part number: 04.037.912.2, lock prong 125 degree, tfna, bp55.Lot number: l018417.Part number: 04.037.912.4, wave spring, shim ended, bp55.Lot number: h089448.Part number: 04.037.912.3, tfna lock drive, bp58.Lot number: h182197.Part number: 21127, timoagri16.00, bp80.Lot number: h210695.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.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: 10MM/125 DEG TI CANN TFNA 400MM/LEFT - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10129285
• MDR Text Key: 194467384
• Report Number: 2939274-2020-02655
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982095893
• UDI-Public: (01)10886982095893
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 04.037.031S
• Device Catalogue Number: 04.037.031S
• Device Lot Number: H225115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2020
• Initial Date Manufacturer Received: 05/22/2020
• Initial Date FDA Received: 06/08/2020
• Supplement Dates Manufacturer Received: 06/22/2020; 07/16/2020; 07/27/2020
• Supplement Dates FDA Received: 07/02/2020; 07/17/2020; 07/29/2020
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES.; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM.; UNK - GUIDES/SLEEVES/AIMING: AIMING ARM.; UNK - GUIDES/SLEEVES/AIMING: SLEEVE.; UNK - GUIDES/SLEEVES/AIMING: SLEEVE.; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA.; UNK - NAIL HEAD ELEM: TFNA LAG SCREW.; UNK - NAIL HEAD ELEM: TFNA LAG SCREW.; UNK - NAIL INSERTION HANDLES.; UNK - NAIL INSERTION HANDLES.; UNK-INSERTION INSTRUMENTS: CONNECTING SCREW.; UNK-INSERTION INSTRUMENTS: CONNECTING SCREW.
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR