MAUDE Adverse Event Report: SYNTHES GMBH 9 TI CANNULATED TIBIAL NAIL-EX/315-SILE; NAIL, FIXATION, BONE

Model Number	04.004.343S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on an unknown date, during a tibial nail, the surgeon was unable to separate the nail from the insertion handle at the end of the case.After repeated attempts the surgeon was forced to remove the nail and hardware and insert a new nail.The procedure was completed successfully with a surgical delay of 60 minutes.The patient status/outcome was positive.This complaint involves one (1) device.This report is for one (1) 9 ti cannulated tibial nail-ex/315-sile.This is report 1 of 1 for complaint (b)(4).
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.Additional narrative: device available for evaluation: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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.
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.D4: expiration date added.H3, 4h, h6: the 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.A manufacturing record evaluation was performed for the sterile finished lot number, and no non-conformances were identified.Product code: 04.004.343s, lot number: 553p063, manufacturing site: mezzovico, release to warehouse date: 28 dec 2021, expiration date: 01 dec 2031.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that one of the edges of the proximal end of the 9 ti cannulated tibial nail-ex/315-sile was bent outwards, probably when the surgeon was trying to disassemble it from the connecting screw/insertion handle.The inner threads of the proximal part of the nail that mate with the connecting screw do not present any signs of damage that could contribute to the complained condition.Expert nailing system titanium cannulated tibial nail surgical technique was reviewed.The following relevant notes were found: - confirm that the nail is securely connected to the insertion handle, especially after hammering, using either the 8 mm ball hex screwdriver or the cannulated shaft with 8 mm hex.- do not strike the insertion handle directly.While no root cause can be determined for the reported issue, the observed condition of the nail was consistent with a random component failure that may have been caused by exposure to unintended forces while assembling/disassembling with its mating device.A dimensional inspection was unable to be performed due to post manufacturing damage.A functional test was unable to be performed as the mating device was not returned for investigation.The complaint condition could not be replicated.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 9 ti cannulated tibial nail-ex/315-sile would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9 TI CANNULATED TIBIAL NAIL-EX/315-SILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16315970
• Report Number: 8030965-2023-01501
• Device Sequence Number: 8813662
• Product Code: JDS
• UDI-Device Identifier: 10886982083890
• UDI-Public: (01)10886982083890
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,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 Model Number: 04.004.343S
• Device Catalogue Number: 04.004.343S
• Device Lot Number: 553P063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 03/15/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/14/2023; 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2021
• 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: UNK - NAIL INSERTION HANDLES
• Patient Age: 49 YR
• Patient Sex: Female