MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 2.5MM TI ELASTIC NAIL 440MM-STERILE; PIN,FIXATION,SMOOTH

Catalog Number 475.925S

Device Problem Break (1069)

Patient Problem Adhesion(s) (1695)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

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.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) 2020, during removal surgery, one of the two titanium elastic nails was successfully extracted, but the other one broke into two.The broken part was left in the patient¿s body.On (b)(6) 2019, the patient underwent an unknown surgery for humeral diaphyseal fractures.Two (2) titanium elastic nails were used for the surgery.After the bone union was confirmed, removal surgery was performed on (b)(6) 2020 and the nail broke.The removal surgery was completed with a 180-minute delay.The patient was reported as stable after the procedure.On (b)(6) 2020, the patient underwent the revision surgery.In the revision surgery, the surgeon tried to remove the remaining broken nail, but he couldn¿t, and it was left in the patient.The surgeon fixed the distal humerus with a plate, which was a competitors product, and the surgery was completed.Concomitant devices reported: hammer guide (part number unknown, lot unknown, quantity 1), long locking pliers (part number unknown, lot unknown, quantity 1), locking slide hammer (part number unknown, lot unknown, quantity 1), titanium elastic nails (part number unknown, lot unknown, quantity 1).This report involves one (1) 2.5mm ti elastic nail 440mm-sterile.This is report 1 of 1 for (b)(4).

• Brand Name: 2.5MM TI ELASTIC NAIL 440MM-STERILE
• Type of Device: PIN,FIXATION,SMOOTH
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10350776
• MDR Text Key: 201244268
• Report Number: 8030965-2020-05531
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 07611819247987
• UDI-Public: (01)07611819247987
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K971783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 475.925S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2020
• 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
• Treatment: UNK - ELASTIC NAILS; UNK - IMPACTION INSTRUMENTS: TRAUMA; UNK - IMPACTION INSTRUMENTS: TRAUMA; UNK - PLIERS
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR