MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS: LFN; NAIL,FIXATION,BONE

Device Problem Device-Device Incompatibility (2919)

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

Event Date 02/08/2021

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown nail/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 during the surgical procedure the cephalic screws guided by the frame were placed.When the final x-rays were taken, it was discovered that the screws are outside of the nail.In the wash the frame was tried with another nail and was correct.This report is for one (1) unknown nail.This is report 3 of 4 for (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.H6: photo investigation: the device was not returned.A photo-investigation was performed on the received images.Two images were received: one intra-operative fluoroscopy image with all devices represented, and one photo image of the assembled construct with all devices except the screws.The fluoroscopy image confirmed the reported condition of the screws not placed appropriately through the nail.The post-operative photo of the assembled construct indicated there were no alignment issues with the construct.No device identifiers were visible.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.Conclusion the complaint was confirmed overall during investigation due to the condition noted in the fluoroscopy image.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.A root cause could not be determined as the post-operative photograph of the assembled construct indicated there was no issue with the device; it is possible the construct was misassembled during the surgery.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.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: UNK - NAILS: LFN
• Type of Device: NAIL,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11406939
• MDR Text Key: 240024392
• Report Number: 8030965-2021-01577
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/08/2021
• Patient Sequence Number: 1
• Treatment: AIM-ARM F/LFN; UNK - NAIL INSERTION HANDLES; UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention