MAUDE Adverse Event Report: SYNTHES SALZBURG 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.016.035S

Device Problems Break (1069); Failure to Align (2522)

Patient Problem Sedation (2368)

Event Date 02/24/2016

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).This device was not implanted.The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reports an event in (b)(6) as follows: it was reported that during surgery to treat a proximal humeral fracture on (b)(6) 2016, the surgeon inserted the nail by hammering because his attempt at manual insertion was not successful.While attempting to insert the screw, the drill bit interfered with the nail.The surgeon removed the nail and found the connection portion of the nail was broken and the insertion handle was not properly orientated.The surgeon then inserted a different nail but he could not insert the nail deep enough into the patient's bone and the proximal part of the nail protruded approximately 5mm from the bone.The patient has a limited range of motion as a result of the nail protrusion.The surgery was delayed 90 minutes due to the reported events.The surgeon commented that the events were due to his usage of the hammer and not a product problem.The surgeon is planning to remove the nail when synostosis of the fracture is confirmed.This report is 1 of 6 for (b)(4).

Manufacturer Narrative

Additional narrative: subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.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.

Manufacturer Narrative

A product investigation was completed: we have received the article 04.016.035 multiloc proximal humeral nail left ø 8.0mm for investigation.The visual investigation of the complained nail shows that the proximal end (connection point) is badly damaged and also a small piece is broken off.The shaft is in good condition besides of some scratches and small marks.Because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.The manufacturing document shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.The device met the specifications at the time of manufacturing and distributing in january 2016.Failure in material or production could not be detected.In the complaint description is reported, that the surgeon inserted the nail by hammering.Based on these findings it is likely that a mechanical overload during insertion caused this complaint.The current technique guide 036.001.247 with following statements: do not hammer, as this may increase the risk of iatrogenic fractures.If nail insertion is difficult, choose a smaller diameter nail or ream the intramedullary canal to a larger diameter.No indication for product related issue was found.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.

• Brand Name: 8MM TI MULTILOC PROX HUMERAL NAIL/LEFT/CANN/160MM-STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5492638
• MDR Text Key: 40078759
• Report Number: 3009417901-2016-10008
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK103002
• 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,Followup,Followup
• Report Date: 02/24/2016

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
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 04.016.035S
• Device Lot Number: 5937269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/10/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/25/2016; 04/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 50