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

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unk - nails: hindfoot arthrodesis nail /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.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 on an unknown date that the patient underwent for hindfoot arthrodesis nail procedure.During the surgery, the jig and sleeves were not aligning with the nail and it made difficult to drill through the tibia for the 2 (two) most proximal screws.The drill bit was tapped in with a mallet and screws were firing medial to lateral, there was 25 minutes delay.The surgery was completed successfully.There was no patient consequence.Concomitant device reported: unknown insertion handle (part#: unknown, lot#: unknown, quantity: 1).This complaint involves four (4) devices.This report is for (1) unk - nails: hindfoot arthrodesis nail.This is report 2 of 3 (b)(4).

• Brand Name: UNK - NAILS: HINDFOOT ARTHRODESIS NAIL
• 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: 10524903
• MDR Text Key: 208373733
• Report Number: 8030965-2020-06864
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/16/2020
• Initial Date FDA Received: 09/11/2020
• 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