MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 9 375 / STERILE; NAIL, FIXATION, BONE

Catalog Number	04.043.145S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024 , while implanting a tibial nail advanced 9 x 375mm the 2.5mm reaming rod became stuck inside the nail when trying to remove the reaming rod.The nail had to be removed with the reaming rod still stuck in it.It was replaced with a reaming rod and nail of the same sizes.Prolonged anesthesia, higher amount of x-rays, and higher soft tissue irritation.There was a surgical delay of 35 minutes.The procedure completed successfully.There was no patient consequences.This report involves one (1) tibial nail-advanced / 9mm 375mm / sterile.This is report 1 of 1 for (b)(4).
Additional 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, h6: the subject device has been 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.
Additional 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.H11 additional narrative: h3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device found nothing indicative of a device nonconformance.The mating device remains stuck on the nail.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.The overall complaint was not confirmed as the observed condition of the tibial nail-advanced / 9 375 / sterile would not contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.H3, h6: device history record (dhr) review conducted: a manufacturing record evaluation was performed for the finished device product code # 04.043.145s-us lot # 533p265 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 23-dec-2021 manufacturing site: jabil bettlach expiry date:30-nov-2031 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: TIBIAL NAIL-ADVANCED / 9 375 / STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19475655
• Report Number: 8030965-2024-07152
• Device Sequence Number: 7025226
• Product Code: JDS
• UDI-Device Identifier: 10886982297655
• UDI-Public: 10886982297655
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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 Catalogue Number: 04.043.145S
• Device Lot Number: 533P265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/01/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.5 REAMING ROD BALL TIP/950-STERILE
• Patient Age: 24 YR
• Patient Sex: Male