MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - NAILS: TFNA; ROD, FIXATION, INTRAMEDULLARY

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2020; however exact date of event is unknown.This report is for an unk - nail: tfna/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).Investigation summary: reviewing x-ray, the complaint description can be confirmed that the tfna nail is proximal through the blade hole broken off.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) 2020, the patient underwent for a revisional surgery of proximal femoral fracture to convert total hip replacement due to tfna nail was broken.The procedure was completed successfully.The patient was experiencing adverse condition.Concomitant device reported: unknown tfna helical blade (part#: unknown, lot#: unknown, quantity: 1), unknown locking screw (part#: unknown, lot#: unknown, quantity: 1).This complaint involves one (1) device.This report is for (1) unk - nails: tfna.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10657735
• MDR Text Key: 215308318
• Report Number: 8030965-2020-07833
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 09/19/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2020
• Initial Date FDA Received: 10/09/2020
• 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