MAUDE Adverse Event Report: SYNTHES GMBH RETROGRADE FEM NAIL ADVANCED Ø11 L200 5°; SCREW, FIXATION, BONE

Catalog Number 04.233.120S

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in (b)(4) as follows: it was reported that on (b)(6) 2023, the patient underwent an unknown surgery with the nail and ksi¿s pad instruments.The surgeon checked the image with the sleeve in place just before drilling ap and ml holes and confirmed that it was a regular circle, before the drilling was performed.However, the drill bit interfered at the proximal hole.The surgeon tried drilling again, the drill bit flowed into the first hole and interfered again.Once in the distal hole, a regular circle was confirmed, the dill bit was hit with the hammer and was advanced to the front of the contralateral cortical bone.The power tool was attached, and the contralateral side was opened.Proximal drilling was performed with the drill bit in place, and there was interference.The screw was inserted in the same way as the distal side.Procedure was completed successfully with thirty(30) minutes delay.According to the surgeon, the rigidity of the device is very weak and guessed that the devices might be too far away from the nail, making it easier to bend at the slightest impossibility.Surgeon confirmed by looking at the x-ray, that there was no damage to the drill bit and no pieces left in the patient.This report is for one (1) retrograde fem nail advanced ø11 l200 5°.This is report 1 of 1 for complaint (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: common device name: hsb.Complainant part is not expected to be returned for manufacturer review/investigation.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.

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.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Manufacturing location: monument; manufacturing date: 25-feb-2022; expiration date: unknown; part number: 04.233.120s, 11mm/rfn/200mm/ 5 ang/ster/poly inlay; lot number: 605p233 (sterile); lot quantity: (b)(4).Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿drill bit interference with holes throughout surgery¿ does not indicate breakage of the nail or any of its components.Therefore, review of the raw materials would not be pertinent to the reported 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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: RETROGRADE FEM NAIL ADVANCED Ø11 L200 5°
• Type of Device: SCREW, 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: 16390250
• MDR Text Key: 310163559
• Report Number: 8030965-2023-01945
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 07612334210944
• UDI-Public: (01)07612334210944
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K201346
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.233.120S
• Device Lot Number: 605P233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA.; UNK-DRILL BIT.