MAUDE Adverse Event Report: SYNTHES GMBH UNK - NAIL HEAD ELEMENTS: HELICAL BLADE ROD, FIXATION, INTRAMEDULLARY

Device Problem Migration (4003)

Patient Problems Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unk - nail head elements: helical blade/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Reporter is a j&j sales representative. 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 underwent the surgery for the trochanteric femur fracture with pfna in question. After surgery, the blade penetrated the bone head. The original fracture was an intramedullary fracture with an inverted bone head, but the patient's activity was low, and a comprehensive judgment was made in consideration of operation time, etc. , and as a result, the fracture was fixed in a way that only closed reduction left the intramedullary form. This report is for one (1) unk - nail head elements: helical blade. This is report 1 of 1 for (b)(4).

• Brand Name: UNK - NAIL HEAD ELEMENTS: HELICAL BLADE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12375456
• MDR Text Key: 268452002
• Report Number: 8030965-2021-07238
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/26/2021 Patient Sequence Number: 1