MAUDE Adverse Event Report: SYNTHES GMBH 11MM TI CANNULATED RETROGRADE FEMORAL NAIL-EX/260MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.013.532

Device Problem Use of Device Problem (1670)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/12/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Additional device product codes: hwc.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Initial reporter is a synthes employee.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.(b)(4).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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021, the patient's rafn nail with 2 screws was removed.The patient was operated on for 24 hours because the nail was short.The surgeon placed an implant that was too short for fracture reduction.Another operation was performed for reduction with osteosynthesis material.This report involves one (1) 11mm ti cannulated retrograde femoral nail-ex/260mm.This is report 2 of 3 for (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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, h4, h6: part # 04.013.532 synthes lot # h409705 supplier lot # n/a release to warehouse date: july 19, 2017 manufacturing location: monument no ncr's were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.

• Brand Name: 11MM TI CANNULATED RETROGRADE FEMORAL NAIL-EX/260MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12592709
• MDR Text Key: 278112698
• Report Number: 8030965-2021-08490
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819792883
• UDI-Public: (01)07611819792883
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K033618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.013.532
• Device Lot Number: H409705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: RAFN; UNK - NAIL HEAD ELEMENTS: RAFN SPIRAL BLADE; UNK - SCREWS: NAIL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Sex: Female