MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAILS; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown nail/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.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 was admitted to the hospital with right subtrochanteric fracture of femur due to a fall injury.On (b)(6) 2021, the patient underwent closed reduction and internal fixation.X-ray taken on (b)(6) 2021 reveled that one nail head was retracted, and the patient complained of pain and discomfort at the tail of the nail.The patient was readmitted to the hospital for internal fixation adjustment on (b)(6) 2021.The two screws were removed and replaced with femoral mode locking device.No additional information could be provided.This report is for (1) unknown nail.This is report 2 of 5 for complaint (b)(4).

• Brand Name: UNK - NAILS
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 12454037
• MDR Text Key: 271000891
• Report Number: 8030965-2021-07642
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR