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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

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.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 during an emergency procedure on (b)(6) 2019, the surgeon planned to place a 10 mm diameter nail and verified in situ that it had not been delivered.Instead, the surgeon attempted to place a 9 mm nail, however, its entrance to the canal could not progress; it was changed to an 8 mm x 315 nail.The nail was placed with resistance and displaced the fracture.When locking the nail in the distal hole, the drill bit progressed without difficulty.In the next hole, a slight resistance was felt and a strange noise was heard; a type of cortical noise.The drill bit broke.The surgeon selected another drill bit.The drill entered to a certain extent and then encountered resistance.Again, the drill bit broke.After reviewing the two drill bit fragments in the bone space, the surgeon decided to leave them in the patient.Procedure outcome is unknown.There was no reported patient consequence.This report is for an unknown nail.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - NAILS
• 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: 8902480
• MDR Text Key: 154590337
• Report Number: 8030965-2019-67389
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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
• Date Manufacturer Received: 07/19/2019
• 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