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

Device Problem Failure to Align (2522)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).510k: this report is for an unknown guides/sleeves/aiming: aiming arm/unknown lot.Part and lot number are unknown; udi number is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown date, the patient underwent an unknown procedure using an expert a2fn cannulated nail.During the operation, the surgeon used an unknown old reamer set to ream with an 11.5mm diameter, however, the nail was difficult to insert into the femoral bone and had to withdraw it and replaced with a new reamer set.Unfortunately, the proximal part of the nail that connected to the jig has been bent during insertion and decided to withdraw the procedure that led to an inaccuracy of an unknown drill bit to pass through the proximal hole.Thus, the surgeon had to change with another nail to complete the procedure.The procedure was successfully completed with four (4) hours surgical delay and the patient had to undergo prolonged anesthesia.There was no patient harm reported.Concomitant medical products reported: unknown drill bit (part# unknown, lot# unknown, quantity 1); unknown reamer set (part# unknown, lot# unknown, quantity 1); unknown jig (part# unknown, lot# unknown, quantity 1).This complaint involves five (5) device.This report is 5 of 5 for (b)(4).

• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6103142063
• MDR Report Key: 8484438
• MDR Text Key: 140958976
• Report Number: 8030965-2019-62507
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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: 03/11/2019

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: 03/11/2019
• Initial Date FDA Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention