MAUDE Adverse Event Report: SYNTHES SALZBURG 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.019.240S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Paralysis (1997)

Event Type  Injury  

Manufacturer Narrative

(b)(4).A revision procedure has not taken place or been scheduled as of yet.The complainant part has not been removed from the patient and, therefore, is not available for evaluation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Device history record review: manufacturing location: (b)(4).Manufacturing date: april 30, 2015 - expiry date: april 1, 2020.Sterilization took place at external supplier in (b)(4).A review of the work order following the sterilization procedure showed that (b)(4) pieces were checked and released for sale.No deviations were noted or non-conformance reports generated.Device 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 (b)(4) reports an event in (b)(6) as follows: it was reported that a patient experienced post-operative radial nerve paralysis sometime after a surgical procedure performed on (b)(6) 2016 to treat a humeral diaphyseal fracture.At this time, it is unknown if the implant caused the event.The surgeon indicated that there was no reaction to or stimulation from the patient's nerve during the procedure, which involved drilling and screw insertion.The procedure was reportedly completed without complication.However, the surgeon stated that it is possible that the radial nerve was pinched into the fracture site during device repositioning.The surgical assistant further elaborated indicating that the middle oblique hole of the distal fixture was located very close to the radial nerve.Therefore, the radial nerve might have been tucked into the screw head during insertion.The reaction was said to have been around the area of distal fixture, and that the diaphyseal area was not paralyzed.At this time, the patient is recovering and participating in rehabilitation therapy.No plans have been made to remove the implants.(b)(4).

• Brand Name: 8.5MM TI MULTILOC HUMERAL NAIL LEFT/CANN/240MM-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: terry callahan ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5755793
• MDR Text Key: 48354447
• Report Number: 3009417901-2016-10020
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK120807
• 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: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 04.019.240S
• Device Lot Number: 5934066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention