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

Catalog Number	04.043.145S
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint (b)(4).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: d9: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.H3/h6: the product was not returned to depuy synthes, however photos were provided for review.Investigation summary: the photographs were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.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 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.Device history lot a manufacturing record evaluation was performed for the finished device product code: 04.043.145s-us.Lot number: 6147p87.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 16-june-2023.Manufacturing site: jabil bettlach.Expiry date: 31-may-2033.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 an unknown date, patient had a distal tibia fracture.After reaming to appropriate diameter, the surgeon inserted the tibial nail into the canal.After the surgeon inserted the nail, he decided he needed to remove the nail and ream again after placing a blocking wire.Upon removing, it was discovered that the poly inlay fell out of the distal portion of the tibial nail into the patient's inter medullary canal.The damaged poly inlay was removed successfully, and was unable to be re-inserted into the nail.A new nail of the same size was opened, and inserted into the patient.There were patient status/ outcome / consequences reported.This report is for one (1) tibial nail-advanced / 9mm 375mm / sterile this is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h6: a product investigation was conducted.The product was returned to depuy synthes for evaluation.Visual inspection of the returned device revealed that the polyethylene inlay of the tibial nail-advanced / 9 375 / sterile which should be located at the distal tip, is missing as it has fell apart from the site and did not return for examination.Therefore, this condition caused that the implant to be unable to assemble due to the disintegration.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.A dimensional inspection was not performed due to post manufacturing damage.A functional evaluation was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the tibial nail-advanced / 9 375 / sterile would contribute to the complained device issue.Based on the investigation findings, and 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.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 there was a five (5) minutes of surgical delay.Patient outcome is reported as positive with new nail.

• Brand Name: TIBIAL NAIL-ADVANCED / 9MM 375MM / 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: 19226768
• Report Number: 8030965-2024-05683
• Device Sequence Number: 6864829
• Product Code: JDS
• UDI-Device Identifier: 10886982297655
• UDI-Public: (01)10886982297655
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: 6147P87
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 05/16/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown