MAUDE Adverse Event Report: SYNTHES GMBH 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.016.038S

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Manufacturer Narrative

Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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) 2021, the patient underwent the surgery for the left proximal humerus fracture with the nail for right.During the surgery, the surgeon found that the wrong side nail was arranged.The surgeon used the wrong side nail carefully and the surgery was completed successfully within 30 minutes delay.The patient condition was stable.No further information is available.This complaint involves one (1) device.This report involves one (1) 9.5mm ti multiloc prox humeral nail/rt/cann/160mm-ster.This is report 1 of (b)(4).

• Brand Name: 9.5MM TI MULTILOC PROX HUMERAL NAIL/RT/CANN/160MM-STER
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11246475
• MDR Text Key: 229612536
• Report Number: 8030965-2021-00710
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819431041
• UDI-Public: (01)07611819431041
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103002
• 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,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.016.038S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2021
• 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