MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC RADIOLUCENT INSERTION HANDLE FRN; ROD, FIXATION, INTRAMEDULLARY

Model Number 03.033.001

Device Problem Device-Device Incompatibility (2919)

Patient Problem Not Applicable (3189)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: synthes employee.Complainant part is not expected to be returned for manufacturer review/investigation.Patient code: no code available used to capture the patient¿s nail surgery.Without a lot number the device history records review could not be completed.Product was not returned.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) 2019, during a bilateral femoral nail surgery the surgeon realizes as he¿s going down, he taught the nail was going to be a little too long.The driving cap has been pulled right out of the insertion handle, a little tip broke there, he got the tip out, but he had already hit.Broken that off and then hit the aiming arm with the hammer somewhat in this piece flying.The sales consultant gives him the conical extractor so they can take the nail came out easily, no need for him to do that, anyhow, they got through the case but they're damaged.The aiming arm barely set back into the insertion handle, they had to going to play with that a little bit in order to get them to fit back to each other.They did, the sleeves lined up but again the driving cap is ruin, the tip¿s broken off, and there's visible damage and its uncomfortable with being competitive those sleeves will line up to the course stunning holes when you want to place the screws.There were a fifteen (15) minutes surgical delay.Procedure was successfully completed.Patient status was unknown.Concomitant device reported: unknown sleeves (part #: unknown, lot #: unknown, quantity #: unknown), unknown hammer (part #: unknown, lot #: unknown, quantity #: 1).This is report 1 for 4 (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.Awareness date reported on follow up 1 report as 8/24/2019 but should have been 10/11/2019.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.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: RADIOLUCENT INSERTION HANDLE FRN
• 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: 9104392
• MDR Text Key: 159623658
• Report Number: 2939274-2019-60773
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982271051
• UDI-Public: (01)10886982271051
• Combination Product (y/n): N
• PMA/PMN Number: K172157
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.033.001
• Device Catalogue Number: 03.033.001
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA
• Patient Age: 29 YR
• Patient Weight: 59